Clinical Sociologist Job Description Sample
Vice President, Clinical Services - Lead Clinical Development At This Top Medical Communication Agency
- The people are awesome, smart and collaborative
- Great culture and the work is dynamic, always looking at issues from many perspectives
- This is a rapidly growing company with significant opportunities for advancement
- Advanced degree in life sciences, PhD, PharmD, MD, or other
- 15+ years experience in medical education/medical communications or similar field
- Experience leading and developing junior staff members
Day-to-Day Activities Activities for the Vice President, Clinical Services
- Identify and achieve the strategic needs of Client’s branded products by developing content around brand product messaging and needs
- Build and maintain strong client relationships and partners effectively with cross function team leads
- Provide medical insights, contributing creative ideas, and developing high quality content
- Encourage and motivate team members to reach their fullest potential
- Conduct unique literature searches through conventional and/or nontraditional sources and develop enduring materials including slide decks with speaker notes, brochures, discussion guide and digital assets
- Oversee and manage resources, both internal and external, to ensure on-time/on-budget production of deliverables
- Identify clinical resource staff needs, recruit, and handle freelance writers as well as plan, assign, and direct work to Medical teams
- Ensure clinical accuracy of all work completed and that all work aligns with all applicable Government and industry regulations and guidance
- Provide proposal research support, assist in the development of new business pitches, new business proposals, budgets and responses to RFPs and RFIs and will attend and present at pitch meetings, as needed
- Stay on top of trends in the medical/scientific community
- Attend and facilitate medical/legal/regulatory approval reviews
- Their clients are global pharma and life sciences companies developing ground breaking treatments and making medicines both affordable and accessible
- Their work excels at supporting clients in their mission of improving care for patients around the globe
- Folks here are comfortable to take charge and work as teammates others can count on delivering extraordinary work
Manager, Clinical Research - Clinical Research - Serv Admin
Job Title: Manager, Clinical Research | Clinical Research - SERV ADMIN | Fargo
State: North Dakota
Department : CLINICAL RESEARCH - SERV ADMIN
Job Schedule: Full Time
Hours Per Shift: 8 hr
Responsible for the day-to-day project coordination, oversight and evaluation for research projects, and the associated billing, compliance and budget management for the projects. Create Medicare Coverage Analysis (MCA) for all studies that involve human subject research.
Create internal budgets and budget analysis for multiple studies. Monitor attendance, work schedules and assign daily work activities. Ensure the completion of study activities in compliance with protocol, and that study staff acquires appropriate training and certification.
Comply with all regulatory and safety requirements and monitor staff in regards to compliance. Provide quality assurance checks for externally completed MCA, internal budgets and budget analysis to review for accuracy and compliance. Assist Research IT with completion of patient study calendar builds in Velos.
Present approved MCA to compliance team for review and approval. Must be able to create and document workflows to assist in billing compliance. Maintain and update important contact list of key stakeholders related to billing.
Research and apply current trends and updates on clinical trial billing, participate in billing workgroups, attend webinars and provide education and updates to the internal team. Conduct billing audits and support other internal or external auditors, investigate and resolve compliance issues related to the healthcare environment and clinical trial billing. Evaluate regulatory agency reports and formulate responses and corrective actions.
Maintain logs, indexes, files, computer databases and other records pertaining to clinical trial billing compliance and risk. Confer with management staff regarding clinical trial billing compliance risk areas and final reports. Provide assistance to other study sites, input and manage evaluation activities, including providing guidance on evaluation questions and outcome measurements.
Must acquire in-depth knowledge of study protocols and standard operating procedures. Create policies and procedures and design site specific tools to enhance efficiency and accuracy in completing study tasks. Serve as the lead for new project startups at their local sites.
Responsible for submission and maintenance of regulatory documentation. Work closely with others to communicate study needs and concerns in a timely manner. Serve as the liaison with community partners to communicate program objectives, encourage recruitment and ensure compliance with study protocol.
Must possess the ability to work collaboratively with a research group or team. Occasional local travel between sites may be required.
Applies an assigned technique for critical thinking in a decision-making process. Maintains sense of commitment to success, personal achievement and satisfaction.
Proceeds without seeking unnecessary permission. Plans, conducts, and documents screening interviews. Confidently takes appropriate disciplinary action when necessary.
Analyzes budgets for patterns and causes of budgeting inaccuracies. Applies organization's operating principles and practices within own business unit. Establishes positive working relationships with associates from various backgrounds.
Communicates well downward, upward, and outward. Applies an assigned technique for critical thinking in a decision-making process. Maintains sense of commitment to success, personal achievement and satisfaction.
Proceeds without seeking unnecessary permission.
No additional department details required at this time.
Certification through Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) required. Certification must be obtained within three years from hire date.
May be required to hold a current valid Category II drivers license. Bachelor's degree in biology, phycology, microbiology or related field with at least five years of clinical or clinical research experience or six to eight years of relevant work experience required.
About Sanford Health:
At Sanford Health, we are dedicated to the work of health and healing.
Every day, we show that commitment by delivering the highest quality of care to the communities we serve.
We are leaders in health care and strive to provide patients across the region with convenient access to expert medical care, leading-edge technologies and world-class facilities.
In addition to strong clinical care, we are also committed to research, education and community growth.
We engage in medical research to not only discover innovative ways to provide care, but also cures for common diseases.
We continuously seek new ways to achieve our vision of improving the human condition here in your community,
across the region and around the world.
The entire team at Sanford Health recognizes the value of healthy families and communities.
We continue to gain momentum and expand our reach. Together, we can make a positive difference now, and in the future.
Sanford is an EEO/AA Employer M/F/Disability/Vet.
If you are an individual with a disability and would like to request an accommodation for help with your online application,
please call 1-877-673-0854 or send an email to email@example.com .
In compliance with federal law requiring employers to verify new employees' U.S.
employment eligibility, Sanford participates in E-Verify. To learn more click here for English Version at https://e-verify.uscis.gov/emp/media/resourcesContents/EverifyPosterEnglish.pdf or here for Spanish Version at https://e-verify.uscis.gov/emp/media/resourcesContents/EverifyPosterSpanish.pdf .
State: North Dakota
Job Function: Research
Job Schedule: Full Time
Req Number: req23911
Clinical Research Director/Sr. Clinical Research Director
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Clinical Research Director/Sr. Clinical Research Director provides medical input to all aspects of product development, for new and innovative treatments being developed in patients. Will serve as scientific and medical member for clinical team(s) working closely with clinical project lead, the regulatory Lead, and the operational lead(s) for overall programs within the therapeutic area. Develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists. Acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.
Responsibilities and Job Duties
- Collaborates with colleagues in clinical development and operations, research, bio
Pharma development and manufacturing, regulatory affairs, and product safety to participate in protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for new products that will ensure regulatory approval and commercial success.
Ensures that study design is scientifically robust, suitable to test the trial's hypothesis, and likely to meet the objectives of the study while ensuring the safety of the patients participating in the Company's sponsored clinical trials.
Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration and provides clinical and medical perspective to preclinical development programs.
Responsible for medical components of the design, execution, and reporting of study protocols as well as (in collaboration with other team members) labeling and regulatory communications under the direction of the clinical leader or delegate.
Directly develops or guides development of scientific/medical portions of clinical study reports, safety reports, and regulatory submissions to assure production of high quality documents.
Directs protocol implementation, including site identification and communication, attend investigators' meetings, correspond with sites including IRBs, and interact with operations teams.
Supports data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts.
Organizes clinical advisory boards, steering committees and data safety monitoring boards as required.
Acts as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
Ensures the feasibility of the study by incorporating study design elements that are ethical and consistent with standard of care and applicable local practices.
Responsible for establishing and maintaining communications with prominent clinical investigators in his/her particular field of expertise.
Works with international colleagues and with external Alliance partners on research initiatives and regulatory issues.
Serving as an information resource to the Company with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
Oversees and provides leadership to colleagues involved in clinical trial execution.
Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.
Education & Credentials
M.D., with subspecialty board eligibility/certification in oncology
Clinical Research Director
Minimum of 3 years of successful clinical research and/or drug development experience in biologics
Experience in immuno-oncology clinical research
Prior clinical development experience for/in the pharmaceutical/biotechnology industry or academic medical setting.
Possesses early phase clinical development experience
Sr. Clinical Research Director
Minimum of 5 years of successful clinical research and/or drug development experience in biologics
Several years of experience working in the field of oncology
Possesses a mix of both early and late phase clinical development experience
Two years of clinical development experience for/in the pharmaceutical/biotechnology industry setting.
Knowledge, Skills and Abilities
Ability to collaborate effectively with many functional areas and a positive track record of working within the team setting
Understanding of the unique product safety, clinical development and regulatory requirements of biological products
Well-regarded for intellectual strength and achievement as a clinical scientist
Effective influence and relationship management skills with internal and external partners
Demonstrate the ability to think creatively and strategically
Strong analytical and problem solving skills
Excellent written and oral communication skills demonstrating ability to organize, interpret and communicate complex information effectively and succinctly including formal and informal presentations
Strong understanding of principles of GCP, ICH and CFR
Working understanding of statistical principles and guidelines as these apply to clinical trials
None at this time
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled
For more information about our commitment to equal employment opportunity, please click here.
Clinical Instructor - Clinical Professor
Clicking "Apply Now" opens the link in a new window.How to ApplyPlease send cover letter and Curriculum Vitae to:
James E. Carpenter, M.D.,
Professor and ChairHarold and Helen Gehring Professor
Department of Orthopaedic Surgery
University of Michigan Health System
2912 Taubman Center
Ann Arbor, MI 48109-5328
The University of Michigan Department of Orthopaedic Surgery and the VA Ann Arbor Healthcare System is seeking an Orthopaedic Surgeon to serve as Chief of Orthopaedic Surgery at the Ann Arbor VA Hospital. The majority of this appointment (60-80%) would be spent in clinical care, teaching, and administrative work at the VA Hospital, with a complementary portion in clinical practice at the University of Michigan. This is a faculty position at Michigan Medicine with full involvement in the academic program in the Department of Orthopaedic Surgery. Clinical experience and expertise in general orthopaedic care, sports medicine, or adult reconstruction would be the most appropriate qualifications. Candidates from groups under-represented in the field are encouraged to apply.
The VA Hospital—Ann Arbor is the center of care for over 69,000 veterans with almost 700,000 outpatient visits per year and a full set of medical subspecialties staffed by University of Michigan Faculty. This VA has a vital set of research program with centers of excellence in clinical and health services research. The Orthopaedic Service at the VA includes Michigan Orthopaedic Residents and Physician Assistants. Expectations for candidates include:
Board Certified in Orthopaedic Surgery (ABOS) and participation in MOC or a candidate to become certified in the next three years
Subspecialty fellowship trained (or certified) in Sports Medicine, Adult Reconstruction, or equivalent experience
Demonstration of outstanding teaching and clinical care abilities
Scholarly interests as demonstrated by publications in peer-reviewed journals and evidence of ability ot obtain external funding
Experience working with and teaching residents, medical students and other trainees
Willingness to provide shared weekend and evening call coverage
Advanced degree in Engineering, Kinesiology or a related field with experience and interest in clinical and translation research focused in bone and joint health is preferred
Work schedule: 4 to 6 Eights VA effort; remainder of effort at University of Michigan
Degree of doctor of medicine or an equivalent degree resulting from a course of education in medicine or osteopathic medicine
Current, full and unrestricted license to practive medicine or surgery in Michigan
Most be board certified or eligible for certification in Orthopaedic Surgery
This position is posted as Clinical Instructor/Clin Asst Prof/Clin Assoc Prof/Clinical Professor. The rank of the selected candidate will depend on qualifications.
Applicants must meet physical standards for the position. A physical examanination priort to placement is required. This is a designated drug testing position. After appointment, you will be subject to random testing for illegal drug use. Requires lifting 15-44 pounds; pushing (approx. 2 hrs.); reaching above-shoulder; use of fingers and both hands; walking and standing from 3-5 hours and kneeling. Ability for rapid mental and muscular coordination simultaneously. Hearing aid is permitted:
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act.
U-M EEO/AA StatementThe University of Michigan is an equal opportunity/affirmative action employer.
- Job Opening ID 162751
- Working Title CLINICAL INSTRUCTOR - CLINICAL PROFESSOR
- Job Title CLINICAL PROFESSOR
- Work Location Ann Arbor Campus
Ann Arbor, MI USA
Full/Part Time Full-Time
FLSA Status Exempt
Organizational Group Medical School
Department Orthopaedic Surgery
Posting Begin/End Date 9/12/2018 – 9/19/2018
Career Interest Instructional - Regular Clinical
Senior Clinical Trial Manager (Sr. Ctm), Clinical Operations
Ra Pharma is a clinical stage biopharmaceutical company that combines expertise in complement biology with proven leadership in peptide chemistry to transform the lives of patients with serious and life-threatening disorders. Ra's proprietary peptide chemistry discovery engine identifies drug candidates that combine the diversity and specificity of antibodies with the favorable pharmacological properties of small molecules. Our primary clinical focus is on rare diseases associated with complement dysregulation.
Description: Ra Pharma is seeking an experienced and energetic candidate to join their growing Clinical Operations team. This candidate will report directly to the Senior Director, Head of Clinical Operations. The Sr. CTM will be responsible for overseeing clinical trial activities on assigned studies. This will include managing outside vendors in the execution of clinical trials and development of relationships between the Sponsor and site personnel.
The Sr. CTM will be responsible for a broad scope of varying activities to support department and corporate goals. Primary responsibilities for this position are to:
Manage clinical research studies within budget and on schedule.
Manage activities of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
Update the Clinical Team on timelines and milestones for the study.
Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
Participate in study site selection; review and update site specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
Oversee clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze clinical data.
Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
Review and negotiate contracts.
Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.
Develop SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team.
Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.
Limited travel possible to field sites to supervise and/or monitor clinical studies (< />
QUALIFICATIONS: The ideal candidate should have a minimum of 5 years industry experience. Experience in rare diseases is highly desirable. The candidate must have a BA/BS degree or equivalent in a health science field. The candidate will have strong oral and written communication skills with monitoring, study management, and SOP-development experience. The ideal candidate will be highly adaptable, proactive, deadline- and detail-oriented, and will maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications. Quality (GCP) and/or Data Management experience is a plus. The candidate will work independently under general direction in a fast-paced environment.
To apply: Email resume to email@example.com
We provide a highly stimulating working environment coupled with a high level of intellectual challenge. We offer a very competitive salary and benefits program. Ra Pharmaceuticals, Inc. is an equal opportunity employer committed to embracing and leveraging diverse backgrounds. M/F/D/V
RN Manager Clinical Operation Pacu
Embrace a spirit of continual improvement and possess a relentless drive towards excellence.
Be accountable for the 24/7 operations of their defined unit(s).
Be accountable for the quality of care delivered and outcomes of areas under their leadership.
Establish an environment where healing and wellness are optimized and the core values of the organization are realized for both our patients and caregivers.
Lead effective care delivery through strong caregiver engagement, wise use of resources, and compassionately hold others accountable for their behaviors and actions.
Assemble and develop effective teams of caregivers and lead these teams in a complex and changing environment.
Be accountable for unit adherence to all applicable laws, regulations, policies, contracts, procedures, and standards of performance.
Develop and mentor their direct reports and plans for succession.
Be informed by the highest level of evidence available when developing standards and modifying care delivery systems.
Required qualifications for this position include:
Bachelor of Science in nursing (BSN)
Current Oregon Registerd Nurse (RN) license
Current Basic Life Support (BLS) at time of hire
American Heart Association Basic Life Support (AHA-BLS) for Healthcare Provider within 6 months of hire
5 years in nursing (PACU) with experience in progressive leadership roles
Preferred qualifications for this position include:
Master's degree or higher in a related field
CPAN or CAPA certification
Formal coursework in management, finance, and other administrative subjects
Previous management experience
RN Clinical Manager Home Health
In This Position You Will:
Provide oversight of all patient care services and personnel. Oversight must include the following:
Make patient and personnel assignments;
Coordinate patient care;
Assure that patient needs are continually assessed; and
Assure the development, implementation, and updates of the individualized plan of care.
Coordination of appropriate patient assignments
Coordination of lab results to all physicians.
Review of required documentation, facilitates interaction between field staff, office staff, the home care patients, and their physicians.
Required qualifications for this position include:
Current unencumbered California RN license
Basic Life Support ( BLS ) certification
Current California Driver's License
Minimum 3 years' of Home Care experience
Minimum 3 years' supervisory/management experience
Knowledge of CMS 5 Star Ratings
Strong verbal and written communication skills
Able to interact effectively with all levels of health care personnel
Meets minimum CA state requirement for auto insurance
Must be able to perform the physical requirements of the position as defined on the RU-91 form
Preferred Qualifications For This Position Include
California Public Health Nurse certification
Certified Home Health Care Manager
Clinical & Informatics Educator OR
Education BSN or BachelOR's degree in health care or related field required, OR four(4) yearsof experience in directly related field. Graduate of accredited school of nursing. High School Diploma or General Education Development(GED) required.
License, Certification, Registration Current California RN license required. BLS certificate required. Additional
Knowledge of Nurse Practice Act, federal, state, and local requirements. Demonstrated knowledge in KP HealthConnect including functionality and expertise in workflows(or for external hires, similarly integrated medical record). Demonstrated knowledge of medical center policy and procedure requirements, specialty training and competency requirements. Must be able to work in Labor/Management Partnership environment.
Preferred Qualifications: Masters degree in nursing, education, or other closely related field preferred. Demonstrated knowledge in performance improvement practices preferred. AORN certified Previous experience as perioperative educator experience preferred.
Director, Clinical Quality
? BS required, Masters preferred CPHQ certification require 5 yearsexperience in Leadership role in acute care ??
RN Clinical Manager Neonatal Intensive Care
In this position you will:
Consider factors related to safety, effectiveness, cost, and impact on practice in the planning and delivery of nursing and other services.
Provide visionary leadership in the professional practice setting and the profession.
Direct and administer assigned functions to ensure high quality, cost-effective patient services which meet or surpass accreditation standards.
Interact with and contributes to the professional development of peers and colleagues.
Stay informed of current evidence-based protocols and standards for the management for patients in the area of responsibility.
Advocate for the protections and rights of individuals, families, communities, populations, healthcare providers, nursing and other professions, and institutions and organizations, especially related to health and safety.
Required qualifications for this position include:
Graduate of an accredited/approved school of nursing
Bachelor's degree in nursing (BSN)
Licensed as a Registered Nurse (RN) in the State of Alaska
Certification in clinical specialty within 12 months of hire
3 years of recent management or supervisory experience
Preferred qualifications for this position include:
2 years of management experience in like-sized unit
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