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Clinical Research Administration Specialist
2 months ago
Whitman-Walker Health is seeking a highly skilled Clinical Research Administration Specialist to join our team. As a key member of our research administration team, you will be responsible for coordinating all administrative, contractual, financial, and regulatory/compliance aspects of our clinical research portfolio.
Key Responsibilities:- Coordinate feasibility requests, protocol development and approvals, budget and contract negotiation, site and monitoring visits, regulatory compliance, and fiscal oversight and reporting.
- Ensure compliance with all laws, policies, regulations, and terms/conditions as they apply to each unique study and support Principal Investigators and project teams in maintaining ongoing compliance.
- Process new clinical research awards and agreements to ensure the best possible fiscal and risk management positions of the Institute and support the management of the ongoing financial viability of the clinical research program.
- Ensure compliance with all licensing, credentialing, and other regulatory requirements for both staff and facilities/equipment within the clinical research program.
- Oversee all clinical research pharmacy operational and personnel needs related to clinical studies and lab facilities.
- Lead/attend all site and monitoring visits.
- Ensure the ongoing compliance of all clinical research staff with relevant federal, sponsor, and agreement-specific regulations.
- Oversee all Institutional Review Board (IRB) and other relevant compliance-related records.
- Monitor all clinical research for reportable events and coordinate the internal and external documentation, submission, and review of such records.
- Bachelor's degree or at least 5 years of equivalent experience required.
- A minimum of 5 years of relevant work experience in a clinical, healthcare, or health research setting, with at least 2 years within research or clinical trials administration.
- Certified in clinical research administration or the ability to begin a program to obtain certification within 6 months of hire from a relevant professional organization.
- Demonstrated commitment to research to achieve health equity and experience working with a broadly diverse population and ability to work harmoniously with diverse groups of individuals.
Whitman-Walker Health is an equal employment opportunity employer and does not discriminate against applicants, its employees or former employees based on race, color, religion, gender, marital status, sexual orientation, national origin, age, disability, veteran status, and gender identity.
