<p>Employment Type:</p> <p>Full time</p> <p>Shift:</p> <p>Day Shift</p> <p>Description:</p> <p>Institutional Review Board Specialist - St. Joseph's and St. Peter's Health Systems</p> <p>Position Summary:</p> <p>Responsible for coordinating the operations of SJH/SPHP (IRB), the IRB Coordinator is the main resource person on regulatory and administrative matters pertaining to protecting the rights and welfare of human research participants.</p> <ul> <li>Ensures that submitted research is reviewed efficiently and in compliance with state, federal and local regulations, and IRB policies and procedures by quality checking all submissions prior to IRB review. </li><li>Coordinates the day-to-day operations of the IRB and facilitates regular, expedited and special meetings of the IRB when necessary. </li><li>Provides accurate and timely IRB correspondence and written reports (approval letters, periodic project review notices, etc.) required by IRB action, policy and regulations. </li><li>Obtains, prepares and distributes meeting agendas and materials for review by the IRB in an accurate and timely manner; compiles and writes minutes. </li><li>Effectively communicates with investigators, IRB Chair, Research Office Staff, IRB Members, and others as deemed appropriate. </li><li>Works with Institutional Official, IRB Chair, IRB Lead Staff, Integrity & Compliance leadership, Director Office of Clinical Research, and other appropriate individuals to prepare for audits by regulatory agencies. Acts as representative to external corporations and agencies, including the FDA and OHRP. </li><li>Ensures rosters are compliant with federal requirements. </li><li>Maintains electronic and paper IRB files and databases. Generates IRB reports. </li><li>Responsible for billing for IRB services. </li><li>Maintain current knowledge of evolving research regulations, guidelines, and compliance requirements. </li><li>Participates in the development and implementation of IRB policy and procedure. </li><li>Supports site visits and/or internal or external audits to ensure compliance with IRB policy and human subjects protection regulations. </li><li>Ability to travel to both Albany and Syracuse New York. </li></ul> <p>Experience Requirements:</p> <ul> <li>One to three years' experience in regulatory affairs/clinical research. </li><li>Knowledge of federal, state and local regulations pertaining to research, to include FDA, DHHS, OHRP and HIPAA. </li><li>Familiarity with medical terminology. </li><li>Excellent computer skills including database proficiency and Microsoft Office. </li><li>Effective communication skills, both verbal and written. </li><li>Ability to problem solve, cooperatively and independently, in a professional manner. </li><li>Strong time management, organizational and interpersonal skills and the ability to prioritize and process large volumes of work with a high degree of accuracy and attention to details. </li></ul> <p>Education Requirements:</p> <ul> <li>BS in health-related field required. </li><li>MS in health-related field preferred. </li><li>IRB Certification, either a Certified IRB Manager (CIM) through the National Association of IRB Managers and/or a Certified IRB Professional (CIP) through the Public Responsibility in Medicine and Research (PRIM&R), preferred. </li></ul> <p>MISSION STATEMENT:</p> <p>We, St Joseph's Health and Trinity Health, serve together in the spirit of the Gospel as a compassionate and transforming healing presence within our communities.</p> <p>VISION:</p> <p>To be world-renowned for passionate patient care and outstanding clinical outcomes.</p> <p>CORE VALUES:</p> <ul> <li>In the spirit of good Stewardship, we heal by practicing Justice in fostering right relationships to promote common good, Reverence in honoring the dignity of every person, Excellence in expecting the best of ourselves and others; Integrity in being faithful to who we say we are. </li></ul> <p>Pay Range: $42.60 - $56.20</p> <p>Pay is based on experience, skills, and education. Exempt positions under the Fair Labor Standards Act (FLSA) will be paid within the base salary equivalent of the stated hourly rates. The pay range may also vary within the stated range based on location.</p> <p>Our Commitment</p> <p>Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are 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, veteran status, or any other status protected by federal, state, or local law.</p>