Regulatory Compliance Coordinator

About the Position

The Regulatory Compliance Coordinator prepares, submits and maintains regulatory documents related to research; serves as principal administration liaison for projects; develops and maintains recordkeeping systems and procedures; prepares documents including interim and final progress reports which support research projects. About the Project Support cutting-edge research to investigate non-invasive ways to measure and modulate sleep in US Warfighters. Learn more about our Lab here: https://www.swordusuhs.org/ Salary Range $55,000 - $81,000.

Salaries are determined based on several factors including external market data, internal equity, and the candidate’s related knowledge, skills, and abilities for the position.

Qualifications

Bachelor’s degree or equivalent work experience required, advanced degree preferred 2-4 years’ experience in clinical research experience required 1-3 years’ experience in staff, research or project management preferred 2-4 years non-profit, research, or healthcare experience desired IRB submission and/or compliance monitoring experience required Experience using online IRB management systems preferred Detailed knowledge of regulatory requirements for conducting human subjects research, including ICH/GCP guidelines, FDA, DHHS, and OHRP regulations preferred Demonstrate competence in oral and written communication Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner Ability to execute the vision of the organization in response to changing conditions Ability to provide strong leadership, innovative thinking, creative planning, and effective motivation skills to staff Ability to be flexible with changing priorities and available to interact with employees, clients and sponsors of all levels Ability to exercise independent judgment in fast-paced, high-pressured environment with strict deadlines and to manage multiple projects Ability to develop strong trusting relationships in order to gain support and achieve results Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software Responsibilities Comply with all rules and regulations as applicable to assigned duty station Maintains all investigator Curriculum Vitaes, all staff license and certification requirements and all other regulatory document as necessary Develops and maintains working relationships with local and regional human protections administrators (HPA) and IRB staff.

Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance during clinical studies and trial conduct. Prepare and/or tracks Institutional Review Board (IRB) annual reports, protocol amendments and addendums, IRB submissions, protocols, informed consents, statements of work, contracts and budgets as related to the statement of work Prepare and files study…

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