Sr. Research Protocol Specialist - Office of Clinical Trials - Remote
About the position Independently executes the overall management of the clinical trial development, maintenance, and completion process. Directs large, complex, multi-center, and 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 protocol/clinical research documents through the clinical trial development/implementation process; writing of the informed consent document; coordination of study logistics/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. Actively participates on committees, task forces and leads 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. Responsibilities • Independently manage the clinical trial development, maintenance, and completion process. • Direct large, complex, multi-center, and investigator initiated clinical research protocols/programs. • Coordinate the writing of protocol/clinical research documents. • Manage pre-written protocol/clinical research documents through the clinical trial development/implementation process. • Write informed consent documents. • Coordinate study logistics/approvals and verify content to meet standards. • Communicate with study sites, industry partners, and federal agencies. • Develop clinical trial budgets. • Provide consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors. • Work in a team environment and manage multiple projects at various stages. • Participate on committees and lead projects as assigned. • Write and develop standard operating procedures and working instructions. • Educate and serve as an expert resource for other research personnel. Requirements • Master's degree with 2 years experience in the clinical research setting or related field. • Bachelor's degree with at least 4 years of experience in clinical research or related field. • Associate's degree with 6 years experience in the clinical research setting or related field. • Proficient in the use of computers and Microsoft applications. • Project management experience required. • Proficient in research systems and leveraging tools and technology. • Knowledgeable with regulatory documents, IRB submission, and writing consent forms. Nice-to-haves • Previous study start-up experience. Apply tot his job