Provides administrative oversight, coordination and support for Institutional Review Committee (IRC) program activities within John Muir Health. The IRC Administrator has direct administrative oversight and coordination to protect the rights, welfare and privacy of human subjects participating in research studies. This includes facilitating the research review and approval process to ensure institutional compliance with federal and state laws, regulations, institutional policies and guidelines governing human subject research. This position provides expertise regarding interpretation and application of government regulations and laws, and all operational processes related to human subject protections.
Conduct intensive administrative pre-review of new or continuing research submissions and consent forms for protocol consistency, completeness and accuracy as well as adherence to all applicable federal/state regulations and institutional policies and guidelines governing human subject research. Resolves administrative discrepancies and deficiencies prior to IRC Committee review.
Provides accurate, timely documentation, processing and tracking of studies and actions in research database.
Manage expedited approvals by reviewing, determining approval route, recommending revisions, coordinating submissions and drafting approvals.
Establishes IRC agenda, manages meeting logistics and produces official minutes for full board meetings including required findings by the IRC and summaries of the discussion of controverted issues.
Attends regular IRC full board meetings to ensure appropriate administrative oversight of human subject protection policies and procedures are being applied effectively and are consistent with Assurance accepted by Office of Human Research Protections (OHRP). Ensures quorum and conflict of interest requirements are met for each protocol review.
Prepares approval letters and consenting materials. Uploads documents to research database for use and distributes to researchers as required.
Maintains membership and rosters, files (with Med Staff Office) including calendar and notifications ensuring compliance with federal/state regulations and institutional policies.
Provides guidance and consultation to IRC board members and staff, investigators and research staff regarding federal and state law and IRC policies and procedures.
Consult with Organizational Official, IRC Committee Chairs, Med Staff or Legal Counsel on IRC matters as necessary.
Advise on forms, policies and processes and maintain ongoing readiness and facilitate all FDA audits.
Assists with the implementation of program enhancements and service improvements.
Conducts IRC education, training, monitoring, auditing, reporting and oversight activities
Perform other job-related duties as assigned.
Works within the framework of John Muir Health and department policies and procedures. Adheres to John Muir Health and department policies and procedures regarding sick time, attendance, rest and meal breaks, standards of professional appearance, and safety.
4 years of administrative experience working with an IRB or within a research setting involving human subjects
Certified IRB Professional (CIP)
Expertise in all FDA and OHRP CFRs, HIPAA Privacy Rule, GCP, all State and Federals Laws pertaining to human subjects protection, proficient in understanding principals of Nuremberg Code, Declaration of Helsinki and Belmont Report, proficiency in electronic data management systems (i.e. Credit) and experienced with FDA audits.
John Muir Health is a nationally recognized, not-for-profit health care organization. It includes John Muir Medical Center, Walnut Creek (554-bed acute care facility) , which serves as Contra Costa County's only designated trauma center and John Muir Medical Center, Concord (245-bed acute care facility).Together, they are recognized as top centers for neurosciences, orthopedics, cancer care, cardiovascular care and high-risk obstetrics. Other areas of specialty include general surgery, robotic surgery, weight-loss surgery, rehabilitation and critical care. John Muir Health also offers complete inpatient and outpatient behavioral health programs and services at our Behavioral Health Center (73-bed fully accredited psychiatric hospital) located in Concord. In addition, John Muir Health provides a number of primary care and outpatient services throughout the community and urgent care centers in Brentwood, Concord, San Ramon and Walnut Creek.
John Muir Health is a collaborative, patient-centered health care environment; listening, explaining and working together as a team, to help patients achieve their optimal health. We recognize those who exemplify excellence, and reward them for contributing to our collective success. From individual to department to spontaneous recognition, Employee Suggestion Program rewards, Employee Success Sharing Program, and many more, we find unique ways to thank our employees for the outstanding efforts they make every day. Competitive salary and benefit package available.
All hospitals are accredited by The Joint Commission, a national surveyor of quality patient care. John Muir Health is an equal opportunity employer.