Under general supervision, serves as the coordinating function for the Human Subject Protections program for SJMHS. This position provides critical management for research oversight through a committee charged with assuring, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in approved research studies. Integral in fulfilling the regulatory requirement of IRB functions and operations as required by law and is the institutional representative of the IRB.
Manages, implements and administers policies and procedures related to research involving human subjects. Serves as a consultant to the IRB committees and investigators regarding current issues and ethical concerns related to research. Ensures that sensitive and confidential issues are concisely and clearly communicated, negotiated, resolved and properly documented as required by regulations, policies and procedures. Serves as the key contact for unanticipated problems occurring in research activities. Serves as key spokesperson to various committees and organizations.
Develops, implements, evaluates and improves operational policies and procedures for the efficient and effective processing of research protocols. Organizes and implements organizational training programs. Prepares inspectional and annual reports for submission to federal agencies such as the Office for Human Research Protection and other regulatory bodies. Performs related responsibilities as require.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
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 regards 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. Maintains good rapport and cooperative relationships. Approaches conflict in a constructive manner. Helps to identify problems, offer solutions, and participates in their resolution.
Maintains the confidentiality of information acquired pertaining to patient, physicians, employees, and visitors to Saint Joseph Mercy Health System. Discusses patient and hospital information only among appropriate personnel in appropriately private places. Assumes responsibility for performance of job duties in the safest possible manner, to assure personal safety and that of coworkers, and to report all preventable hazards and unsafe practices immediately to management. Behaves in accordance with the Mission, Vision and Values of Saint Joseph Mercy Health System. Provides quality patient care by considering the age specific, development and cultural needs through competent clinical practice. Demonstrates unit/area competencies.
REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATION/LICENSURE
Minimum Knowledge and Education: Bachelor’s degree in a science or medical field and 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.
Saint Joseph Mercy Health System (SJMHS) is a health care organization serving six counties in southeast Michigan including Livingston, Macomb, Oakland, Washtenaw and Wayne. It includes 113-bed St. Joseph Mercy Chelsea, 537-bed St. Joseph Mercy Ann Arbor, 136-bed St. Joseph Mercy Livingston in Howell, 443-bed St. Joseph Mercy Oakland in Pontiac and 304-bed St. Mary Mercy in Livonia.
Combined, t...he five hospitals are licensed for 1,726 beds, employ more than 14,000 individuals and have a medical staff of nearly 2,700 physicians.
Saint Joseph Mercy Health System prides itself on providing the highest level services for its patients. SJMHS offers revolutionary cancer care using the state's first CyberKnife; it created an innovative telemedicine program which links patients to leading experts by use of a Stroke Robot; SJMHS doctors proctor other doctors nationwide on leading-edge daVinci robotic procedures including minimally invasive heart bypass; and it is discovering new standards for care to best serve our senior patients with the nation's first Senior ERs.
Saint Joseph Mercy Health System is committed to featuring state-of-the-art facilities to encourage the healing of body, mind and spirit. St. Joseph Mercy Ann Arbor recently opened the doors to two new patient towers. New patient towers are also being constructed in Livonia, Pontiac and Chelsea - all totaling an impressive $700 million investment in the community and the future of the health system.