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Team Lead-Sr Research Protocol Specialist

7 months ago

Rochester, United States Mayo Clinic Full time

This is a hybrid role: Candidate must be able to come onsite for coverage rotation and onsite project work as requested, therefore must be within driving distance of Mayo Clinic Rochester campus. Position could include up to 30% onsite work.

Along with overseeing the overall management of the clinical trial development, maintenance, and completion process, this role involves collaborating on large, complex, multi-center, investigator initiated clinical research protocols/programs. The incumbent will be responsible to accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.

Other responsibilities/duties may include, but are not limited to:

Collaborate with industry partners throughout the study lifecycle process; Provide consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors.

Coordinate the writing of the protocol/clinical research documents and/or the ongoing management of pre-written research documents through the development/coordination of study logistics, obtaining approvals, verification of content to meet institutional, industry, and federal standards. Partner with multidisciplinary stakeholders' enterprise-wide and help them effectively navigate the clinical trials process.  Spearhead an ever-growing dynamic RPS team to shape the future of research.  Write, develop, and provide input to standard operating procedures and working instructions. Educate and serve as an expert resource for other research personnel.

May lead or participate as a member on committees, task forces and lead on projects as assigned.