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Clinical Research Administration Specialist
1 month ago
Whitman-Walker Health is a leading healthcare provider dedicated to delivering high-quality care to the LGBTQ+ community and individuals living with HIV. Our mission is to provide compassionate and inclusive care, while advocating for the rights and dignity of all individuals.
Job SummaryWe are seeking a highly skilled Clinical Research Administration Specialist to join our team. The successful candidate will be responsible for coordinating all administrative, contractual, financial, and regulatory aspects of our clinical research portfolio. This includes feasibility requests, protocol development and approvals, budget and contract negotiation, site and monitoring visits, regulatory compliance, and fiscal oversight and reporting.
Key Responsibilities- Ensure compliance with all laws, policies, regulations, and terms/conditions applicable to each study
- Support Principal Investigators and project teams in maintaining ongoing compliance
- Process new clinical research awards and agreements to ensure best possible fiscal and risk management positions
- Manage ongoing financial viability of the clinical research program through timely and thorough invoicing, expense tracking, and financial reporting
- Ensure compliance with all licensing, credentialing, and other regulatory requirements for staff and facilities/equipment
- Coordinate site and monitoring visits
- Ensure ongoing compliance of clinical research staff with relevant federal, sponsor, and agreement-specific regulations
- Oversee Institutional Review Board (IRB) and other relevant compliance-related records
- Monitor clinical research for reportable events and coordinate internal and external documentation, submission, and review of such records
- Bachelor's degree or at least 5 years of equivalent experience required
- Minimum of 5 years of relevant work experience in a clinical, healthcare, or health research setting
- Certified in clinical research administration or ability to begin a program to obtain certification within 6 months of hire
- Demonstrated commitment to research to achieve health equity and experience working with a broadly diverse population