Senior Clinical Research Associate - (US-MD-Gaithersburg - 20899)

Minimum Education: None
Job Type: Full Time
Jobcode: N/A
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Responsibilities: As directed, oversee protocol development and other critical study documents and templates as appropriate. As directed, contribute to the selection and negotiation with CROs and other Vendors Participate in protocol and Informed Consent Form review sessions. Work collaboratively with all functional areas to facilitate teamwork and communication that will support the success of the clinical study. Work closely with Clinical Trial Team to ensure timely resolution of clinical trial project issues, and the ability to ask and obtain direction from more senior clinical operations staff when necessary. Must display the ability to facilitate strong external partnerships with vendors, CROs, academic clinics, and other organizations and individuals, to proactively identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure study deliverables to time and quality. Employ operational expertise in the preparation of Investigator meetings, monitor training meetings and other meetings. And be willing to create and deliver presentations when applicable. Lead or participate in the set up, maintenance and consistent use of any e-clinical components of the study (e.g. IXRS, EDC, CTMS, etc.) Contribute to activities as directed , (e.g. defining and testing data checks, system User Acceptance Testing), that will progress the availability of tools and programs that facilitate data capture and validation activities. Provide operational expertise to the program manager and input to key documents, (e.g. Clinical Study Report, etc.), and recruitment strategies, as well as contingency strategies for managing risks to clinical operations. Mentor junior clinical team members and serve as a resource for new employees. Participate in review of data listings as requested on relevant studies. .

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