Job Summary:  Key Job Responsibilities
Prepares and submits moderately complex protocols and supporting documentation to regulatory bodies and research committees involved in the pre-award and post-award process. This role submits the continuations, amendments to regulatory bodies and responds to a broad range of questions. Generates reports and maintains files and documentation for compliance with regulatory requirements (federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board) for the assigned study and/or clinical trial. 
 
Primary Duties and Responsibilities
•    Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.
•    Completes forms and generates reports from multiple data sources to comply with the assigned protocals for the study and/or clinical trail. 
•    Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trails.
•    Responds to generally broad data requests and questions. 
•    Monitors the status of assigned regulatory submissions and amendments from end-to-end.
•    Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date.
•    Represents the unit in cross functional meetings and provides updates on the status of assigned regulatory submissions.
•    Supports the unit in internal and external auditing of regulatory documents.
•    Identifies quality and performance improvement opportunities to support efficient workflows.
•    Maintains strict patient confidentiality according to HIPAA regulations and follows guidance according to applicable law, research practices using Good Clinical Practice (GCP) guidelines.
 

Educational Requirements: Bachelor's Degree

Licenses: Certification In Clinical Research (CCRP-Preferred)

Experience: Relative experience in a research related field. (3 years -Minimum)

Physical Demands: Frequently: Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects. Perform continuous operation of a personal computer for four hours or more. Use hands and fingers to handle and manipulate objects and/or operate equipment. Rarely: Perform unaided lifting of objects, 20 lbs