Clinical Research Coordinator managing the conduct of clinical trials at Emory University. Handling administrative activities and overseeing research project requirements and compliance.
About the role
- Oncology Clinical Research Coordinator at WVU managing clinical trials and ensuring protocol compliance. Collaborating with research staff and healthcare providers while advocating for ethical participant care.
Responsibilities
- Ensure compliance with current regulations, guidance and policies at the institutional, state, federal, and international levels.
- Assess feasibility of implementing new protocols.
- Collaborate with investigators, research staff, pharmacy, clinical staff and other ancillary departments to implement and conduct trials.
- Facilitate and participate in monitoring or auditing reviews conducted by internal and/or external agencies such as the U.S. Food and Drug Administration, industry, IRB and quality assurance.
- Serve as a liaison between the research team, clinical staff, and sponsors.
- Provide education to staff prior to implementation and throughout the lifecycle of the research study and monitor protocol adherence.
- Support community outreach and trial advocacy.
- Collaborate with research team utilizing internal and external resources to develop a recruitment strategy for each research study and evaluate effectiveness.
- Ensure the initial and ongoing consent process is performed and documented in compliance with all applicable regulations, guidelines and policies.
- Educate patients on trial participation, providing updates and information throughout the lifecycle of the study.
- Assess for barriers to effective informed consent discussion and implement a plan to overcome as barriers are identified.
- Assess eligibility and monitor patient adherence.
- Ensure scheduling and adherence to all protocol tests and procedures.
- Perform study assessments and/or procedures within the employee’s scope of practice which may include but not limited to vital signs, ECG, administering questionnaires, etc.
- Assess and document adverse events in collaboration with the investigator.
- Collaborate with investigator on dose modifications and treatment responses.
- Advocate for ethical care of participants while adhering to the protocol requirements.
- Maintain accurate source documentation and data reporting.
- Provide protocol training to clinical staff and/or other members of the research team.
- Ensure proper documentation practices from clinical staff and provide additional training, as needed.
- Update the Clinical Trial Management System (CTMS) with protocol and patient information.
- Review trial budgets and coverage analyses for adequacy of funding.
- Distinguish between routine care and research-related expenses.
- Ensure patients are reimbursed for research related expenses and/or stipends provided per protocol/contract.
- Participates in educational opportunities to increase knowledge about oncology and clinical research.
- May lead projects or coordinate team efforts.
- Assist with onboarding and training research staff.
Requirements
- Bachelor's degree from an allied health discipline, or related medical field (such as nursing, medical technology, pharmacy, etc.)
- A minimum of two (2) years of working in a clinical setting and/or experience in clinical research.
- Any equivalent combination of related education and/or experience will be considered.
- If applicable, valid RN license from the State of West Virginia.
Benefits
- 37.5-hour work week
- 13 paid holidays ( staff holiday calendar )
- 24 annual leave (vacation) days per year ( employee leave )
- 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments)
- WVU offers a range of health insurance and other benefits
- 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks.
- Wellness programs
Job title
Job type
Experience level
Salary
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Degree requirement
Location requirements
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