- Responsible for research compliance as dictated by Federal regulations and institutional policies and procedures.
- Provides education and guidance to IRB members to assure that the board is equipped with current tools to protect the safety and welfare of human subjects in research. Knowledgeable of all types of clinical trials to assure that the applicable regulations are considered.
- Assures that institutional policies and practices for documentation requirements for research endeavors are available to researchers to meet or exceed regulatory requirements. Responsible for evaluating clinical studies and associated study documents to assure patient rights and safety are appropriately addressed.
- Evaluates level of risk of human research protocols, consent forms, etc. and advises the IRB.
- Evaluates submissions by researchers that include IRB applications, study protocols, and consent documents to assure the Investigator is in compliance with regulations and institutional policies.
- Once studies are approved, insures that pertinent information about the research study conduct is reviewed, acknowledged and documented. This includes: study protocol and consent changes, deviations and/or revisions, serious adverse events (SAEs), continuing review reports, and study closures.
- Acts as a liaison between the Investigator his/her research team and the IRB, insuring proper documentation and protocol compliance.
- Responsible for the evaluation of the conduct of clinical studies. This may include: subject screening and recruitment; obtaining informed consent; information recorded on case report (data collection) forms and other study documents; maintenance of study records; assurance of patient confidentiality; and may conduct follow-up with research participants to verify adherence to policies and/or study protocol. Educates IRB members.
- Works with all levels of management in regard to clinical research activities. Is responsible for organizing and leading inspectional activities with regulators such as the FDA. Regularly assesses policies and procedures and implements improvement strategies.
- Reviews data obtained from the data safety monitoring, adverse events and auditing functions and will have the authority to recommend to the IRB to stop a protocol if, in his/her judgment, research participants have been, are, or will be placed at risk for serious harm.
- Independently composes and edits complicated and sensitive correspondence; reports and documents related to outcomes and findings of the human subject protection programs.
- Prepares, analyzes and summarizes data from IRB activities to provide descriptive statistics for IO and institutional management.
- Provides regional oversight and IRB services for other locations such as Livingston, St. Mary's Livonia, Chelsea, Mercy Primary Care, Michigan Cancer Research Consortium, and other regional hospitals as required.
- Bachelor's Degree in a science or medical field.
- Seven years of experience which includes at least five years of experience in the management of research activities involving humans and/or animals, OR an equivalent combination of experience, education and training.
- Previous IRB office leadership experience preferred. Advanced degree (MBA, or MS/MA) is desirable.
- Writing skills necessary to draft reports, compose minutes, letters, memos and other written documents.
- Computer (word processing, database, and spreadsheet) skills necessary to prepare a variety of reports and monitor research committee requirements.
- Interpersonal skills necessary to interact effectively with a wide variety of Health System and external agency personnel.
- Organizational skills and flexibility necessary to simultaneously manage a complex office and the tasks associated with the IRB.
- Ability to problem solve complex situations.
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IRB Administrator - Ann Arbor, United States - Trinity Health
Description
Employment Type:Full timeShift:
Day Shift
Description:
As part of the Research Compliance Department, the Institutional Review Board (IRB) Administrator will join a team of additional Administrators and Research billing auditor to focus on research compliance and human subject protection. Full-time benefited position, located primarily in AA with occasional travel serving our locations in the Michigan region.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Minimum Knowledge and Education:
Trinity Health is one of the largest not-for-profit, Catholic healthcare systems in the nation. Built on the foundation of our Mission and Core Values, we integrate diversity, equity, and inclusion in all that we do. Our colleagues have different lived experiences, customs, abilities, and talents. Together, we become our best selves. A diverse and inclusive workforce provides the most accessible and equitable care for those we serve. Trinity Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by law.
