Sr. Research Protocol Specialist - Office of Clinical Trials
Sr. Research Protocol Specialist - Office of Clinical Trials
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Job Description
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.
Qualifications
Masters degree with 2 years experience in the clinical research setting or related field. OR Bachelors with at least 4 years of experience in clinical research or related field. OR Associates degree with 6 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.
Strong preference will be given to those with previous study start up experience.
Visa sponsorship or transfer is not available for this position. Mayo Clinic does not participate in the F-1 STEM OPT extension program.
Required Experience:
Senior IC
Employment Type
Full-Time
