Apply for Vacancy for Clinical Trials Administrator at Weill Cornell Medicine in the USA. The deadline for this job is 30th September 2021.
Oversees multi-disciplinary clinical research and related activities for specified programs and/or disease area(s). Additionally, this role also manages the day-to-day operations, including regulatory, data management and administrative aspects for these program(s).
- Ensures compliance with regulatory audits/inspections and/or internal reviews. Develops and recommends corrective action plans to address deficiencies identified. May serve as liaison to audit team(s) during on-site visits.
- Similarly, serves as central point person for program related matters and issues. Provides guidance on research-related questions within the program. Troubleshoots potential issues and facilitates smooth clinical study operations among research team.
- Likewise, oversees research billing compliance for cooperative group clinical trials. Ensures that Human Research Billing Analysis Forms (HRBAF) are completed in an accurate and timely fashion for all studies and are referenced and adhered to as studies progress.
- Also, serves as liaison with the Food and Drug Administration (FDA), as indicated, to obtain Investigational New Drug (IND) number or exemption.
- Assists leadership with developing and implementing strategies to build and grow the program’s clinical research portfolio.
- Provides regulatory support for program and/or disease area(s) as necessary.
- Furthermore, responsible for dissemination of research-related billing information and policies to clinical trials staff and investigators. Similarly, ensures a timely receipt of payment for studies. Develops and maintains system to track income and charges incurred.
- Bachelor’s Degree in related field
- Approximately 3 years of experience in health-related role, in clinical or research setting
Knowledge, Skills and Abilities
- Experience with regulatory, data management, and billing compliance aspects of clinical research.
- Also, experience with conducting and carrying out protocols and research coordination.
- Furthermore, familiarity with IRB interaction, regulatory policies, database input and report generation.
- Likewise, research experience in an academic health center with exposure to a team research environment at all levels (senior investigators, nurses, research coordinators, lab technicians.
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