Clinical Research Coordinator - Dept Of Surgery Embedded

Mayo Clinic • Phoenix, AZ

3d

About The Position

Independently coordinates complex (i.e. interventional, therapeutic greater than
minimal risk) clinical research protocols with minimal direction from the
principal investigator and/or supervisor in compliance with regulatory laws and
institutional guidelines. Collaborates with research team to assess feasibility
and management of research protocols. Ensures implementation of research
protocols after IRB approval and provides information as appropriate for
progress reports. Screens, enrolls, and recruits research participants.
Coordinates schedules and monitors research activities and subject
participation. Identifies, reviews, and reports adverse events, protocol
deviations, and other unanticipated problems appropriately. Manages, monitors,
and reports research data to maintain quality and compliance. Provides
education/training for others within the department. Performs administrative and
regulatory duties related to the study as appropriate. Some travel may be
required.

Responsibilities

• Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s).
• Gives direction to and works cooperatively with other research staff.
• Collaborates with various departments within the institution.
• Works cooperatively with other investigators and personnel at all levels.
• Interacts with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies.
• Ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards
• Communication with study sites and/or federal agencies regarding study status changes
• Federal and Institutional Review Board (IRB) document preparation and submission
• Provides consultative expertise regarding regulatory and policy requirements.
• 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.
• Participates in other protocol development activities and executes other assignments as warranted and assigned.

Benefits

• Medical: Multiple plan options.
• Dental: Delta Dental or reimbursement account for flexible coverage.
• Vision: Affordable plan with national network.
• Pre-Tax Savings: HSA and FSAs for eligible expenses.
• Retirement: Competitive retirement package to secure your future.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees