Oncology Research Regulatory Operations Coordinator

Trinity Health • Ann Arbor, MI

81d

About The Position

Responsible for coordinating regulatory requirements necessary for oncology research trials associated with the Michigan Cancer Research Consortium (MCRC). Works with all study sponsors (federal and industry) to assure MCRC sites meet all standards associated with Human Subjects and Federal regulations appropriate to clinical trials. Provides support to health care providers, clinical research nurses and ancillary departments to assure regulatory needs are met per guidelines. Provides training and professional guidance to investigators, other research coordinators and nurses at sub recipient sites of the Michigan Cancer Research Consortium (14 hospitals in 3 states).

Requirements

• Bachelor’s Degree, preferably in a legal, regulatory or science-based field.
• No experience required. Related data, health care, or previous research experience preferred.
• Demonstrated ability to work closely with Principal Investigators and other stakeholders to coordinate the day-to-day activities required in study coordination.
• Excellent writing and interpersonal communication skills.
• Excellent organization, time management and document management skills.
• Ability to meet set monthly deadlines.
• Knowledge of research design, regulatory requirements, and ethical requirements.
• Working knowledge and utilization of Microsoft computing tools and good basic computer skills, including use of web conferencing and web-based collaboration tools.
• Ability to work both independently and in team-oriented settings.
• Ability to work flexible hours (typically within 8am-5pm) to accommodate study needs and meetings.

Responsibilities

• Coordinates regulatory compliance tasks, documents, disclosures, rostering lists, and completes requirements for preparing research sites to engage in a wide variety of federally-funded and pharmaceutical clinical trials at MCRC affiliated hospitals.
• Reviews clinical trial and institutional policy requirements and ensures acceptable standards per study sponsor and federal guidelines.
• Coordinates with study sponsors to answer questions posed by the staff or investigators, provide information on MCRC SOP's and act as the liaison to clinical team.
• Consults with national research bases and industry sponsors related to protocol on behalf of investigators and patients to assure compliance with protocol and patient safety.
• Provides training, direction, education, orientation to study staff and investigators at all sites affiliated with the Michigan Cancer Research Consortium.
• Secures and monitors study team training compliance documents.
• Coordinates materials for audits and monitoring visits.
• Ensures that all documentation is available and submitted for auditor review.
• Follows up on all necessary corrections.
• Participates in developing any corrective action or improvement plans.
• Recognizes and reports potential adverse events and protocol deviations in cooperation with the Research Nurses, Sub-Investigators, and Principal Investigator.
• Acts as liaison between the Institutional Review Board (IRB), Investigator, clinical departments, and the pharmaceutical sponsor.
• Creates, revises, and submits IRB submissions prior to deadline and communicates submission results to study sponsors and study staff following approval.
• Serves as liaison to other hospitals, outside organizations, and industry representatives on related research study or clinical trial issues.
• Communicates with other areas in the hospital to obtain documents needed to be maintained within study files such as the Lab for reference ranges or certifications held.
• Prepares and maintains Medicare Cost Analysis forms in compliance with research billing needs for pharmaceutical studies prior to opening for enrollment.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees