Team Lead-Sr Research Protocol Specialist - Rochester, United States - Mayo Clinic

Description

Oversees the overall management of the clinical trial development, maintenance, and completion process. May collaborate on large, complex, multi-center, investigator initiated clinical research protocols/programs.

Accurately applies 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.

Responsibilities may include, but are not limited to:

coordinating the writing of the protocol/clinical research documents and/or the ongoing management of pre-written research documents through the development; writing of the informed consent document; coordination of study logistics/obtaining approvals, verification of content to meet institutional, industry, and federal standards; communication with study sites, industry partners, and/or federal agencies and development of clinical trial budgets.

Provides consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors.

Must be able to work in a team environment both as a member and a facilitator, be able to manage multiple projects at various stages, and be able to work independently and provide guidance to the PI and investigative team.

Must be able to work in a complex environment and to exercise good judgment in ambiguous situations.

Must possess excellent problem-solving skills, oral, written, communication and interpersonal skills, and be comfortable interacting with individuals at all levels internal and external to Mayo Clinic.

May lead or participate as a member on committees, task forces and lead on projects as assigned. Writes, develops, and provides input to standard operating procedures and working instructions. Educates and serves as an expert resource for other research personnel.