Research Assistant
About The Position
Under minimal supervision is responsible for the research regulatory and administrative activities of clinical trials for the practice. Plays an integral role in the regulatory/compliance process of all clinical research conducted to include site qualification, and management of the study regulatory documents throughout the site’s participation. Collaborates with research staff and management on process improvement and QA initiatives. May train other employees on regulatory process. Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPAA.
Requirements
- High School Diploma required
- Minimum 3 years of relevant experience required (research, regulatory, or oncology)
- Ability to navigate multiple electronic platforms
Nice To Haves
- Associate degree in a clinical or scientific related discipline preferred
Responsibilities
- Support site qualification and startup preparation
- Manage regulatory documentation
- Coordinate training for protocol updates and amendments
- Maintain SOP, GCP, and IATA training statuses
- Collect and maintain critical regulatory documents
- Serve as liaison with CROs and sponsors
- Coordinate all monitoring and audit visits
- Prepare regulatory packets (FDA 1572, FDQs, etc.)
- Submit to local and central IRBs
- Report on SAEs to sponsors/FDA/IRB
- Facilitate amendment training and documentation
- Support annual IRB continuing review
- Assist with finance packet documentation
- Manage lab kits, stockroom supplies, and IP temperature logs
- Support specimen management
- Perform data entry into vendor eDC systems, when needed
Benefits
- Be part of a practice at the forefront of cutting-edge cancer care and advanced treatments
- Access opportunities for professional growth and continuing education.
- Work alongside a collaborative and compassionate team of experts dedicated to making a difference.
- Enjoy the convenience of multiple locations throughout the Capital Region.
- Contribute to groundbreaking clinical trials that shape the future of oncology care.
- Discover your career potential with a practice dedicated to excellence and innovation.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
101-250 employees
