Clinical Research Coordinator - Rockefeller Neuroscience Institute

West Virginia University • West Virginia, WV

2d • Onsite

About The Position

The Clinical Research Coordinator supports clinical trials (Phases I–IV) at the WVU RNI by coordinating research activities, ensuring protocol compliance, managing patient care, and maintaining data integrity. The role requires independent judgment, collaboration, and adherence to regulatory standards.

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 experience in the following: Working in a clinical setting and/or experience in clinical research
• Any equivalent combination of related education and/or experience will be considered.
• All qualifications must be met by the time of employment.
• 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 – information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
• Treatment design, administration and modification.
• Counseling and education – principles and methods for training design, teaching and instruction for individuals and groups, and the measurement of training effects.
• Data collection, validation, entry, analysis, and reporting.
• Human subjects protection and related issues – knowledge of professional principles (GCP and IRB guidelines), legal and/or reporting requirements affecting grants and contracts, and adheres to industry and government standards.

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.
• 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.

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. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6%25 employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ’s.
• Wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level