Job Description

Accentuate Staffing is partnering with a biopharmaceutical company who is hiring for a Clinical Trial Associate to join their team. This is a direct hire opportunity, offering competitive pay and benefits while working a hybrid work schedule. The ideal candidate is a proven leader in clinical development with study management experience in the pharmaceutical or medical device industry.

Responsibilities:

1. Collaborates with the project team and other CRO/vendor resources and timelines associated with study start-up activities.
2. Initiates and trains sites to the study protocol, ensuring proper site adherence to clinical research regulations.
3. Assists the project leader in maintaining operational plans, which are consistent with strategic corporate and R&D objectives.
4. Plans and manages all materials to support the appropriate execution of clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational product.
5. Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections.

Requirements:

1. Bachelor’s degree or higher in related field combined with three to four years as a CSM or CTM in a sponsor environment.
2. Vendor and site management experience developing RFPs for vendors to support clinical studies.
3. Ability to serve as lead for vetting vendors and sires for study participation as well as being Point of Contact both for CRO and vendor management.
4. Experience leading the development of study specific protocols, consent forms, and other trial related materials.
5. Skilled in ensuring the TMF is continuously updated and all documents are accounted for by the completion of the clinical study report.

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