Clinical Sociologist Job Description Sample
Oncology Clinical Research Specialst - Cancer Institute Clinical Research
The West Virginia University Research Corporation is seeking applications for an Oncology Clinical Research Specialist with the Cancer Institute Clinical Research Unit. This position participates in the development, coordination, and implementation of research and administrative strategies essential to the successful management of clinical trials research.
In order to be successful in the position, the ideal candidate will:
Protocol Compliance: Facilitates compliance with the requirements of the research protocol and good clinical research practice while remaining cognizant of the needs of diverse patient populations.
Clinical Trials–Related Communication: Utilizes multiple communication methods to facilitate the effective conduct of clinical trials.
Informed Consent Process: Demonstrates leadership in ensuring patient comprehension and safety during initial and ongoing clinical trial informed consent discussions.
Management of Clinical Trial Patients: Involves a variety of resources and strategies to manage the care of patients participating in clinical trials, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as management of symptoms.
Documentation: Provides leadership to the research team in ensuring collection of source data and completion of documentation that validate the integrity of the conduct of the clinical trial.
Patient Recruitment: Utilizes a variety of strategies to enhance recruitment while being mindful of the needs of diverse patient populations.
Ethical Issues: Demonstrates leadership in ensuring adherence to ethical practices during the con-duct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data.
Financial Implications: Identifies the financial variables that affect research and supports good financial stewardship in clinical trials.
Bachelor's degree from an allied health discipline or related medical field and/or RN Degree
Four (4) years of experience working in a clinical setting and/or experience in clinical research experience;
Or an equivalent combination of education and experience.
Knowledge of clinical trials research.
Must possess and apply knowledge of many different and unrelated processes and methods related to such areas as:
Patient care; treatment design, administration and modification; counseling and education; data collection, validation, entry, analysis, and reporting; human subjects protection and related issues.
Skilled at being aware of others' reactions and understanding why they react as they do.
Skilled at communicating effectively in writing as appropriate for the needs of the audience.
Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approached to problems.
Knowledge of customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to write reports, business correspondence, and procedure manuals.
Ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Ability to develop specific goals and plans, to prioritize, organize and accomplish tasks independently and through others.
Entry Level Clinical Laboratory Scientist/Clinical Laboratory Scientist/Sr. Clinical Laboratory Scientist (Temporary)
Clinical Laboratory Scientist, (includes CLS Sr., CLS, and Entry Level CLS)
Under the general direction of the Laboratory Director, or their designee, performs pre-analytical, analytical and post-analytical procedures and analyses to provide data for health maintenance, diagnoses, treatment and monitoring of medical conditions. Enhances quality of patient care and service through interdepartmental cooperation and quality assurance protocols.
Correctly verifies that the proper specimen is being analyzed for the correct patients and that the correct test is being performed.
Judges the adequacy and qualities of specimens submitted for testing.
Analyzes clinical laboratory specimens following the standard methods and procedures approved by the Laboratory Director or designee.
Performs quality control procedures to ensure accuracy of clinical data.
Utilizes test reference ranges (including neonates, pediatric and adult) to determine reasonableness of test results.
Validates test results through correlation with test parameters (e.g. Hgb/Hct, anion gap, platelet count/smear, dipstick/micro etc.)
Confirms testing on all Critical Values to ensure accuracy prior to releasing of test results.
Performs routine preventative maintenance and troubleshooting on assigned instruments and equipment according to established schedule and procedure.
Performs and documents instrument function by checking and calibrating specific lab instruments and documents data.
Records on instrument logs any repairs, replacement, and maintenance needed of equipment.
Releases or reports results per Laboratory Standard Operating Procedures.
Trains laboratory assistants on proper techniques/procedures related to clinical laboratory practice.
Performs other related duties as necessary.
Additional Duties and Responsibilities:
- Clinical Laboratory Scientist, Entry Level
- Provides general or direct supervision of Lab Assistants and general Clerical Personnel as required according to lab law and regulations.
- Clinical Laboratory Scientist
- Provides general or direct supervision of Lab Assistants and general Clerical Personnel as required according to lab law and regulations.
- Clinical Laboratory Scientist, Sr.
- Trains laboratory assistants, and other Clinical Laboratory Scientists, on proper techniques/procedures related to clinical laboratory practice. Assist with Quality Assurance and Performance Improvement activities consistent with the Laboratory Quality Plan. Provides general or direct supervision of Lab Assistants and general Clerical Personnel as required according to lab law and regulations.
Sr. CLS minimum 3 years of experience, CLS minimum 6 months of experience, Entry Level CLS = none.
Bachelor's degree in Clinical Lab Sciences or related field. Applicable military experience may be substituted for bachelor's degree.
Current California State Clinical Laboratory Scientist License/Valid Temporary California State Clinical Laboratory Scientist License for entry level CLS.
Computer application experience/proficiency preferred.
Ability to read and comprehend complex instructions, short correspondence, and memos. Ability to write simple correspondence.
Ability to effectively present information in one-on-one and small group situations to customers, clients, and other incumbents of the organization.
Must be willing to work in a Labor Management Partnership environment.
Also refer to Position Specifications outlined in the appropriate collective bargaining agreement.
Primary Location: California,Santa Clara,Santa Clara Hospital 700 Lawrence Express Wy. Scheduled Weekly Hours: 32 Shift: Day Workdays: Mon, Tue, Thu, Fri *Rotating Sat,Sun, Variable days off. Due to operational needs, employee may be required to work on a Wed; Days off during the work week may vary. Expected length of employment up to ninety (90) days Working Hours Start: 7:00 AM Working Hours End: 3:30 PM Job Schedule: Part-time Job Type: Standard Employee Status: Temporary Employee Group/Union Affiliation: ESC/IFPTE - Local 20 - Clinical Lab Scientists Job Level: Individual Contributor Job Category: Laboratory Department: Clinical Laboratory Travel: No Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.
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Clinical Laboratory Scientist / CLS Or Clinical Laboratory Technician / Clt- West Allis, WI Fulltime
Nearly thirty years ago, QuadMed was born out of the idea that health care should be simple. By providing employers and their employees with quality onsite and near-site primary care, with a focus on wellness and prevention, we make a culture of health and well-being possible. Our caregivers working as a team, and with ample appointment times, have the opportunity to build meaningful patient relationships that produce measurable health improvement results. We're proud to be a nationally recognized leader committed to transforming health care for the better. At QuadMed you can showcase your skills and your passion for patient care.
The clinical laboratory scientist is responsible for performing tests and reporting results to the physician for use in diagnosis, treatment and/or monitoring treatment of diseases
Position based out of the West Allis clinic. Schedule: Monday through Friday 8am to 5pm, with an every 6th Saturday rotation 7:30am to 12pm.
Ideal candidates will have Chemistry/analyzer experience within the last 5 years, strong Phlebotomy skills. (Ranging from infant to 65 yrs) And ability to travel to Sussex and Lomira clinics for coverage.
Performs patient and Quality Control (QC) testing, develops skills and maintains competency in all assigned laboratory areas.
Patient tests and Quality Control (QC) material tests are performed and results reported in accordance with Federal and/or State regulations..
Critical values are reported and documented per medical laboratory procedures.
Workload is prioritized and managed to meet expected turn-around-times (TAT).
Competence is maintained, and new skills are added as technologies change.
Maintains proper inventories and correctly uses supplies and reagents.
Inventory needs are communicated in a timely manner.
Reagents are received, stored, and quality is verified properly prior to use following departmental policy and procedure.
Reagents and supplies are utilized according to manufacturer and/or procedural instructions.
Disposal of reagents and supplies is in accordance with safety guidelines.
Performs advanced equipment trouble-shooting and equipment maintenance.
Routine and complex instrument maintenance is performed and documented on a scheduled basis, consistent with department policy.
Instrument malfunctions are recognized and trouble-shooting procedures are initiated in a timely manner and reported to the Laboratory Manager
Manufacturer's Technical Service is contacted for resolution as needed to maintain workflow and to schedule repairs.
Necessary procedures are followed before utilizing equipment after service. Workstations are restocked with supplies to maintain a consistent workflow. Specimen status (pending log, problems, critical values, etc.) is communicated to the appropriate person(s).
Participates in quality, safety, and compliance programs.
Quality issues are reported promptly and accurately.
Suggestions for process improvement, planning, and development are made.
Compliance guidelines are applied to all testing and reporting activities.
Performs phlebotomy: capillary punctures, and venipunctures as appropriate for patients of all ages requiring the procedure.
Follows established safety practices including biohazards, exposure control plan (blood-borne pathogens), infection control to include universal precautions, employee right to know (hazardous chemicals), and chemical hygiene standard.
Promotes effective working relationships as part of a team inter and intra departmentally to facilitate the department's ability to meet its goals and objectives.
Attends all in-service and continuing education as required by health and wellness center, policy, and licensure requirements.
Demonstrates respect and regard for the dignity of all patients, families, visitors and fellow employees to ensure a professional, responsible and courteous environment.
Maintains strict confidentiality of Personal Health Information and adheres to HIPAA regulations.
- Graduate from an accredited college or university with a Bachelor's Degree in Medical Technology or related science required
Phlebotomy experience required
Two years in a clinical laboratory environment preferred
Certificates, Licenses, Registrations:
- Certification as a medical technologist by the Board of Registry of ASCP or the National Certification Agency (NCA or American Medical Technology and licensure required
Knowledge, Skills & Abilities:
Personable, friendly, team orientated
Organized, accurate and detail oriented
Good interpersonal skills to effectively interact with patients and providers
Bilingual a plus
We offer excellent benefits to eligible employees, including 401(k), holidays, vacations and more. In select states, patient care is provided by an independent physician-owned corporation.
Quad/Graphics is an equal employment opportunity employer. The Company's policy is not to unlawfully discriminate against any applicant or employee on the basis of race, color, sex, sexual orientation, gender identity, religion, national origin, age, military or veteran status, disability, genetic information or any other consideration made unlawful by applicable federal, state, or local laws. The Company also prohibits harassment of applicants and employees based on any of these protected categories.
Drug Free Workplace
Clinical Coordinator – Clinical Research Unit, Full-Time, Days
An experienced Registered Nurse, who in addition to providing direct patient care, is accountable for facilitating an interdisciplinary approach to patient care, patient flow, staffing, resource utilization, and problem solving on a given shift. Facilitates unit operations on a shift basis according to policy, procedure, and regulatory requirements. Coordinates unit based staffing assignments on a shift basis to achieve high quality and cost effective care. Directs patient care provided by staff nurses and support personnel for a specific shift. Champions new initiatives and helps in unit/departmental or hospital wide committees/task forces. Communicates directly with patients and significant others about nursing care. Implements appropriate action plans to provide safe, quality, and efficient care. Assures safety and security of patients, significant others, and staff. Provides direct patient care. AA/EOE
Current license as a Registered Professional Nurse in the State of Illinois.
Current BLS certification.
Baccalaureate degree from an accredited school of nursing or equivalent experience as approved by the Patient Care Director; (Minimum two years clinical experience in area of clinical specialty).
Specialty certification in the clinical area of focus.
Additional clinical experience in another clinical area.
Principle/Senior Clinical Data Manager Position Summary: The Principle/Senior Clinical Data Manager Is Responsible For All The Data Management Activities And Deliverables Of Clinical Trials
The Principle/Senior clinical data manager is responsible for all the data management activities and deliverables of clinical trials (Phase I to Phase III). Externally, the Principle/Senior Clinical Data Manager effectively manages Data Management CROs overseeing all outsourced data management activities and ensuring quality and timeliness of deliverables. Internally, the Principle/Senior Clinical Data Manager collaborates with cross functional team members, including but not limited to Clinical Operations, Statistical Programming, Clinical Pharmacology, Medical Writing and Medical Directors to develop and meet project deliverables and timelines. The Principle/Senior Clinical Data Manager needs to be able to function in a fast paced and dynamic environment.
Primary Duties and Responsibilities:
Provide oversight to Clinical Data Management CROs/vendors for assigned trials to ensure data quality, integrity and timelines.
May contribute to the selection of suitable vendors for the outsourcing of Data Management activities. This includes being involved in RFP development, contract negotiation and selection of CRO/vendor, as needed.
Oversee development and review of Case Report Forms (eCRFs), Data Management Plan, Validation Specifications, Data transfer Specifications, etc.
Participate in sponsor UAT of production EDC database release.
Supervise reconciliation activities for data from external data vendors.
Ensure clinical data within EDC is of high quality to support statistical review, interim review, and or final database lock.
Facilitate creating data management reports and metrics.
Ensure deliverables/timelines are met (DSMB, IA and database lock, etc.).
Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs and meet all regulatory requirements.
Assist with developing Data Management best working practices and SOPs.
Performs other duties as required/assigned.
Collaboration & Teamwork: Relates to employees and management in a cooperative manner that helps others to achieve their best.
Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
The ability to convey both written and verbal information effectively and efficiently.
Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
Detail-Oriented: Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments.
Education, prior work experience, and specialized skills and knowledge:
Bachelor's degree required.
About 7-10 years (for Principle Data Manager) or 4-6 years (for Senior Data Manager) relevant clinical data management experiences in pharmaceutical/biotechnology industry.
Experience working in an outsourced data management model.
Proficient in multiple EDC platforms (RAVE, Inform, OpenClinica, etc) and related processes (database build, mid-study database update and database lock, etc).
Knowledgeable about external data reconciliation.
Familiar with CDASH/SDTM CDISC standards.
Conversant on advanced medical terminology.
Good understanding of coding (MedDRA, WHO drug dictionaries).
Able to work and communicate effectively in a small company environment.
Clinical Laboratory Scientist Or Clinical Lab Technician Lead
- Responsible for supervision of technical and support staff involved in the processes of procurement, testing, and reporting in the clinical laboratory on all shifts. Works collaboratively with coordinators, managers, and staff to achieve accurate test results, advance performance improvement and improve financial outcomes as set by the Director of Lab Facilities or Lab Managers. Serves as a technical resource to internal and external customers. Oversees proper scheduling, staffing, and allocation of resources.
Responsible for oversight of technical and support personnel within the general testing and procurement areas on all shifts.
Provides support and leadership, communicating critical information to their shifts.
Makes regular rounds with staff and communicates concerns/needs to manager/coordinator.
Evaluates workload and service requirements to determine staffing and training needs; makes staffing recommendations to manager.
Evaluates workload and workflow in order to optimize turnaround time in all areas of the laboratory.
Utilizes knowledge of workflow in all testing sections to improve and alter processes
Provides input regarding job performance and competency as related to pre-analytical, analytical and post analytical skills for performance reviews
Demonstrates problem solving skills.
Thoroughly investigates and documents all incidents, complaints and concerns. Communicates them upward as necessary and enters them into event reporting system.
Provides coaching and counseling and refers further disciplinary steps to the manager and provides the supporting documentation to the manager.
Oversees the scheduling of and/or creates staffing schedule(s) ; including redistribution of staff as needed to ensure coverage in all areas of responsibility.
Responsible for taking off hour call ins and assuring that vacancy is covered appropriately.
Routinely monitors collection pending reports to ensure all specimens are collected and received appropriately.
Works with management in interviewing applicants, orienting new employees, and coaching current employees.
Demonstrates thorough knowledge of and is responsible for oversight of responsible lab section. If off shift lead then needs thorough understanding of specimen procurement.
Possesses knowledge and ability to perform various LIS and HIS functions/troubleshooting. Particularly as regards specimen receipt into LIS as well as inquiries regarding patient registrations and physician orders.
Works closely with staff to ensure that policies and procedures are followed. Is aware of and communicates procedural changes to staff in both a verbal and written format.
As applicable, schedules staff to cover various client physician offices, nursing homes and main lab.
Provides instruction through skill training as well as functioning as a technical resource.
Responsible for assuring that protocols are followed in labeling pour offs and specimen storage.
Insures that reference materials maintained in section are current and include but are not limited to referred testing; trains staff in proper online usage of reference materials.
Functions as a resource as regards identification of inappropriate specimens and rejection of these specimens.
Observes and enforces safety guidelines as outlined in our Safety Manual.
Coordinates the student rotations and ensures documentation is completed.
Demonstrate and utilizes the knowledge of a certified technician/scientist.
Exhibits critical thinking skills and possesses the knowledge to correlate test results to disease states.
Reviews and investigates complaints, concerns, and problems to determine root causes.
Recommends policy changes and works with staff to implement process changes in the course of problem resolution.
Maintains technical knowledge and keeps up with new technologies and testing strategies in order to provide the most-cost-effective, compliant laboratory testing.
Strives to improve employee satisfaction.
Understands analytical and post analytical processes in the laboratory.
Understands the need to recognize implausible results, unusual test reactions, errors and instrument malfunction and how this affects patient testing.
Using the LEAN philosophy assists staff in organizing their work to provide for minimal turnaround time, assuring their work is performed in a manner that minimizes repeat testing.
Makes independent decision to refer testing to alternate sites if in place systems are not operable.
Maintains competencies to be able to work in responsible section(s) of the Lab.
Exhibits leadership skills and functions as liaison.
Acts as a liaison with both internal and external customers including Nursing Outpatient labs, ED and clients.
Supports CAP inspection process through checklist review.
Manages supply inventory and places orders as required to maintain par levels.
Reviews proficiency test results in a timely manner to meet deadlines.
Participates in staff competency by conducting performance checks on an annual basis.
Performs review of quality control and maintenance function checks.
Fosters a culture within UnityPoint that promotes prevention, detection and resolution of conduct that conforms to established standards, regulatory requirements and business and ethical policies.
Works with Technical Consultant to insure staff turn in proficiency testing in a timely manner.
Supports point-of-care testing within the Medical Center.
Serves as a technical consultant to both internal and external customers.
Maintains expertise in general area to help with educational, technical, and/or support activities as needed.
Meets regularly with staff to discuss daily operations, indicators, customer needs, problems, and changes.
Interacts with medical, technical, and support staff, clients, vendors, coordinators, and administrative personnel effectively. Assists in the communication of compliance issues to staff.
Technical Lead (Blood Bank, Core Laboratory, and Microbiology): MLS (ASCP), MT (AMT) or CLS (NCA) certified, with a minimum of two years of clinical laboratory experience, is strongly preferred. MLT (ASCP) certification or equivalent education and experience, with four years of clinical laboratory experience, would be considered.
2 years of experience in/with clinical laboratory Required.
License and Certification
- Certification by ASCP or equivalent certification body
Required English Skills
- Basic writing skills
Other: Advanced technical/clinical oral skills.
Ability to respond appropriately to customer/co-worker
Interaction with a wide variety of people
Maintain confidential information
Ability to communicate only the facts to recipients or to decline to reveal information
Ability to project a professional, friendly, helpful demeanor
Intermediate computer knowledge: Ability to troubleshoot minor problems within a Windows OS, operates within a network environment, uses spreadsheet, database, word processing and internet applications proficiently. Learns new applications without difficulty and is able to aid others in immediate work area with computer questions.
MS Office Apps
Windows Operating System
Sr Clinical Auditor - Clinical Research Center
Under limited direction, review and approve clinical research studies submitted for DMC review by various investigators and research groups.
Reviews and verifies all DMC assigned research studies are conducted utilizing "Good Clinical Practices" and ensures all policies and procedures are adhered to according to DMC CRO. Conducts complex review(s) of research studies, audits studies, and ensures the accuracy and completeness of all regulatory documents for all DMC studies submitted via the DMC Clinical & Transition Research Office (research review website). Provides both clinical and technical expertise and acts as a liaison and resource to other DMC departments.
Ensures the accuracy and completeness of all regulatory documents for all DMC research studies submitted for review. Monitor clinical studies for follow-up, reporting, and/other research related activities as assigned. Ensures appropriate documentation for all assigned research studies.
Conduct audits when requested, ensures documented charges are correctly billed and billed charges are documented appropriately. Identifies, reports, and recommends actions to improve research processes when appropriate.
Safeguards the assets of the DMC, advocates appropriate levels on internal controls and promotes operating effectiveness and efficiency. Prepares reports for audits when requested.
Must be a team player and able to work independently. Ability to communicate with all DMC affiliates.
Ability to solve complex problems. Ability to follow DMC/Tenet policies and procedures and follow appropriate chain of command.
Ensures documented charges are correctly billed and billed charges are documented in the medical record. Corrects billing errors in the Patient Accounting system and in some cases, the Cerner system.
Identifies, reports and recommends actions to improve charge capture processes. Identifies new services and technology in the clinical setting and facilitates establishment of new charges. Conducts in-service training for hospital personnel to ensure understanding of the importance of effective charge capture and documentation of services performed.
Conducts complex reviews of departmental processes which include registration, clinical activities, documentation and charge capture. Identifies opportunities to maximize billing in accordance with federal and state regulations. Safeguards the assets of the DMC, advocates appropriate levels of internal control and promotes operating effectiveness and efficiency.
Defend the hospitals revenue through research, documentation and negotiation by participating in and acting as a content expert for the hospital in audits conducted by third parties including, but not limited to, Blue Cross Catastrophic audits; HOPP audits; MPRO audits and all commercial insurance audits.
Provides both clinical and technical/billing expertise and acts as liaison and resource for user departments.
Analyzes results, identifies trends and patterns and prepares monthly statistical and narrative reports for various levels of hospital and corporate management. Must be able to adjust on a daily basis.
1.Bachelors Degree in Nursing.
2.Licensed Registered Nurse in the State of Michigan.
3.Three years of patient care experience in a hospital as a Registered Nurse, at least one of which should be in a critical patient care specialty area such as I.C.U., E.R. or O.R.
4.Charge audit or similar experience preferred.
5.One year experience as a Clinical Auditor.
6.One year of Research experience, strongly preferred.
Primary Location: Detroit, Michigan
Facility: Detroit Medical Center Shared Services
Job Type: Full-time
Shift Type: Days
Clinical Research Associate II – Specialist, Clinical Affairs, In House – Irvine, CA – Tmtt
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease.
The In House Specialist, Clinical Research Associate II will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use and will ensure clinical trials are conducted and reported in accordance with all regulatory requirements.
Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities
Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
Assist with clinicaltrials.gov updates
Minimum Education/Experience Required:
- Bachelor's Degree in related field, 3 years of previous experience with regulatory documentation for clinical studies.
Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
Excellent written and verbal communication skills and interpersonal relationship skills
Excellent problem-solving and critical thinking skills
Solid knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
Solid understanding of regulatory submissions, reporting, and audits
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Clinical Research Coord (Rn) - Clinical Research Cancer (Newport Beach, CA, US)
The Research Nurse Coordinator (RNC) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians. The RNC provides support, coordination and leadership for FDA regulated research including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III and IV clinical trials, government funded clinical research and investigator initiated clinical research.
The RNC ensures smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure. This position reports to the Director of Clinical Research.
The RNC is involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow-up, and maintenance of regulatory binders. Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects.
The RNC assists in developing a detailed cost analysis, study budget preparation, and tracking/distribution of study funds. Responsible for submitting case report forms and other data to the Sponsor as necessary, and assists with monitoring, auditing and close-out visits. Maintains knowledge of best practice and standards for Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.
This position reports to the Director of Clinical Research and works as a team member to support growth and vision of the Hoag Institute for Research and Education.
Assist the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensures the safety and welfare of the research participants.
Designs, implements and manages a system for organizing, planning work flow related to all research study activities. Prepares and presents summary of clinical trial activities if needed.
Maintains up to date knowledge of study protocols to complete study activities correctly and completely. Design and/or maintain organizational tools to conduct the study accurately and in compliance with Good Clinical Practice. Develops forms, check-lists and other tools to facilitate study completion and compliance.
Assist the PI in the active recruitment and screening of potential research participants according to the protocol's inclusion/exclusion criteria. Schedule research participant's visits in accordance with study protocol. Assist the PI in the training of other site personnel and other medical staff in understanding and implementing the protocol.
Drafts or reviews template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines and Hoag Policy language.
Discusses research study with potential research participants and answers any questions while coordinating the process of obtaining the research subjects informed consent prior to participation in the study. The RNC shall seek guidance from the Principal Investigator for any questions he/she cannot accurately answer for the research participant regarding the study or participant's medical condition.
Schedule or assist in scheduling follow-up visits for enrolled subjects
Documents and reports Unanticipated Problems, Adverse Events and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH and GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB.
Complete the Case Report Forms for the study accurately and completely. Abstract data from hospital record and physician charts to complete CRFs.
Work with ancillary staff areas (e.g. Operating Nursing Care, Cath Lab, Pharmacy, Pathology, Radiology, Laboratory, Medical Records) within the hospital affected by research activities.
Maintain accurate and complete records of the receipt, dispensing, and return of all investigational supplies, including study drug(s) or devices, and report any discrepancies to the PI and Sponsor.
Maintain required regulatory and other documentation in the study documentation file. Maintain records of research participants enrolled in the study.
Communicate with the study sponsor regarding study activities as necessary. Participates in required study visits such as Initiation Visit, Routine Monitoring Visits, Close-out Visits and audits.
Reviews study records and meets with site visit teams/monitors, the FDA, or other inspectors as designated by sponsor when required. Resolves queries generated from Sponsor or other monitoring/auditing reports.
Completes study Institutional Review Board submission application and ensures Investigator's review. Communicate with the designated IRB on study approvals/closures, and adverse event reporting
Work with the Clinical Research Office (CRO) administrative staff on all required aspects of study submission, continuing reviews, adverse event reporting, and study closure. Maintains current knowledge of Clinical Research Policies and Procedures.
Works with Clinical Research Office administrative staff in developing a detailed cost analysis, study budget preparation, and tracking/distribution of study funds.
Accommodates changes in workload within the department and demonstrates flexibility in accepting work assignments. Performs assignments as directed by Supervisor.
Perform clinical duties and assessments as needed (i.e. blood/lab draw, EKG, record vitals, CPR, BLS, ACLS certificate, taking physician orders, etc.)
Perform other duties as assigned.
Education, Training and Experience
One year of Clinical Research Coordinator experience or at least five years of experience in the specific medical specialty of the position.
Patient coordination experience in complex clinical trial setting required.
Maintain CPR, certifications (BLS, ACLS, NALS, PALS, E.P., etc.) as applicable per hospital policy.
Maintain current license, certification, and registration
Complete annual "house-wide mandatories" per hospital/department requirement
Medical terminology required.
Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines.
Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
Bachelor of Science in Nursing (BSN)
Familiar with the medical area of neurosciences particularly in the areas of stroke, epilepsy, movement disorders and cognitive disease.
- Familiar with medical areas of oncology, neurosciences, cardiovascular medicine, or orthopedic research.
Skills or Other Qualifications
High degree of attention to detail and ability to follow instructions. Good writing, oral and presentation communication skills.
Works well independently. Maintains subject and appropriate study related material confidentiality. Effective interpersonal skills required to interface between departments, other coordinators, investigators, medical records, and Institutional Review committee.
Computer knowledge in Microsoft windows applications including Word, Outlook and Excel and familiarity with electronic data capture systems preferred. Ability to be proficient at additional specialized software and systems required.
License and Certifications
Current licensure in good standing as a Registered Nurse in the State of California
Holds current Certified Clinical Research Coordinator certificate (ACRP or SoCRA), or complete within two years of hire
Clinical Research Program Coordinator, Radiation Oncology Clinical Research
The Clinical Research Program Coordinator provides administrative and patient care services for the coordination on research studies in the department of Radiation Oncology Clinical Research.
The Clinical Research Program Coordinator establishes a system for development of research programs including writing, processing, submission and maintenance of protocols. This position develops and maintains a processing and tracking system for all protocol related paperwork; develops patient care methodology for protocols, including criteria for patient participation; collects and develops criteria information for protocol submission; and develops and writes grant proposals and maintains contact with funding agencies. The Clinical Research Program Coordinator coordinates FDA submissions and supervises all research audits; reviews patient eligibility of potential study cases with research nurses and physicians; maintains schedules for timely submission of grant data; controls randomization of patients; and orients faculty/support staff personnel.
Coordination of activities related to initiation and conduct of clinical trials.
Collaborate with the multidisciplinary team as necessary to achieve objectives of all assigned trials, and maintain good clinical practice.
Maintain data necessary for audits.
Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the Human Subject Research Manual.
Provide support in providing coverage to protocols assigned to other research staff.
Coordination of regulatory correspondence on clinical research studies.
Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies, cooperative groups and /or government sponsors).
Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.
Direct support to clinical trial research protocols.
Review protocol documents including abstracts, text and informed consent for relevant information.
Act as liaison with physicians and research staff in providing administrative services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data and regulatory items pertaining to such studies.
Assist in modifying consents; submit to IRB.
Collaborate with each PI to ensure completeness of protocols prior to review by CRC and IRB.
Ensures grant or contractual funding is reviewed and compliance issues (i.e. Representations and Certifications) are met prior to initiation of protocol.
Educates faculty/support staff personnel on protocol process, compliance regulation, institutional policies and research-related issues and initiatives.
Effectively and consistently communicates project status to all involved parties through project completion.
Required: Bachelor's degree.
Preferred: Master's degree in Nursing, Public Health, Healthcare Administration or related scientific field.
Required: Three years of experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience.
May substitute required education degree with additional years of equivalent experience on a one to one basis.
With preferred degree, one year of required experience.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Employee Status: Regular
Minimum Salary: US Dollar (USD) 50,800
Midpoint Salary: US Dollar (USD) 63,500
Maximum Salary : US Dollar (USD) 76,200
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