Research Protocol Specialist

Mayo Clinic•Rochester, MN

3d•Hybrid

About The Position

Executes the overall management of the clinical trial implementation, maintenance, and completion process in collaboration with protocol development team. Responsibilities may include but are not limited to coordination of the protocol/clinical research documents and/or the ongoing management of pre-written 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; 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 with occasional guidance from physician leadership or management. 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. Active member on committees and task forces and participates on projects as assigned. Writes and provides input to standard operating procedures and working instructions. Develops and carries out staff training and mentoring as necessary.

Requirements

Bachelors with at least 2 years of experience in clinical research or related field. OR associate degree or completion of college diploma program with 4 years experience in the clinical research setting or related field.
Must be proficient in the use of computers, and Microsoft applications.
Project management experience required.
Proficient in research systems, excel in leveraging tools and technology, knowledgeable with reg docs, IRB submission, writing consent forms.
Must be able to work in a team environment both as a member and a facilitator.
Must be able to manage multiple projects at various stages.
Must be able to work independently with occasional guidance from physician leadership or management.
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.

Nice To Haves

SoCra or ACRP certification preferred.

Responsibilities

Executes the overall management of the clinical trial implementation, maintenance, and completion process in collaboration with protocol development team.
Coordination of the protocol/clinical research documents and/or the ongoing management of pre-written 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.
Development of clinical trial budgets.
Provides consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors.
Active member on committees and task forces and participates on projects as assigned.
Writes and provides input to standard operating procedures and working instructions.
Develops and carries out staff training and mentoring as necessary.