Our people make Lehigh Valley Health Network a great place to work. Join us in applying for our Institutional Review Board Coordinator position in the Institutional Review Board department.
Be part of inspiring passion. At Lehigh Valley Health Network (LVHN), the deep connection we have with our patients and with each other is undeniable. In fact, we rely upon each other's strengths and passion to deliver exceptional patient satisfaction and high quality service each and every day.
Lehigh Valley Hospital has ranked among U.S. News & World Report's "Best Hospitals" for 21 consecutive years. LVHN is also a Magnet™ Hospital, recognized three times by the American Nurses Credentialing Center for attracting and retaining the best professional nurses. Finally, Lehigh Valley Hospital received an "A" grade in The Leapfrog Group's Spring 2014 Hospital Safety Score, the highest grade in patient safety. These three recognitions highlight LVHN's commitment to teamwork, compassion, and technology.
Assist in the preparation and organization of the monthly Institutional Review Board (IRB) meetings, agendas, minutes, and post meeting correspondence.
Assist with the conversion from paper to electronic and working within the system.
Assist with the LVH NCI CIRB effort.
Ensure efficient, timely, and customer-friendly IRB operations.
Provide support to investigators regarding all actions involving the IRB process.
Track and advise IRB concerning policy changes and maintains hospital IRB policies and procedures manual.
Assist the hospital in avoiding the risks of patient harm and liability.
Assure compliance with federal regulations and that appropriate measures are taken at a level to insure positive scrutiny by the Office of the Inspector General.
Assist investigators with the electronic IRB (eIRB) submissions of their human research protocols. Ensure that protocols and associated documents submitted for IRB review are appropriate, complete and contain all the required elements to facilitate ethical review by the IRB.
Conduct a pre-IRB review of eIRB applications to ensure that all research and related activities outlined in the protocol are in accordance with ethical guidelines and applicable Federal regulations, policies and procedures.
Make recommendations on the appropriate type of review necessary to obtain IRB approval for the research and triage studies to the appropriate IRB and/or reviewer.
Coordinate all administrative activities before, during and after IRB meetings to facilitate the efficient review and approval of research protocols by the IRB.
Coordinate and/or assist in the coordination of the writing/editing of manuscripts and abstracts submitted to professional and scientific journals.
Participate in developing educational activities for the research community and facilitate or conduct training sessions for HRPP staff, IRB members, investigators, faculty and students in matters related to the ethical conduct of research involving human subjects and other relevant areas as may be required to meet federal, state, DoD regulations.
Perform other functions/duties as directed.
Minimum Requirements: A bachelor's degree in health science or a related field is required. A minimum of three (3) years of experience in hospital research and/or regulatory affairs is required. Must possess a working knowledge of all Federal statutes and regulations pertaining to human subjects research protections. In addition, the successful candidate must exhibit good interpersonal skills in order to express complex ideas, convey critical information, resolve conflict and foster teamwork and productive working relationships. Incumbent will possesses sufficient knowledge of computer use and applications including word processing programs, spreadsheets and electronic submission systems and/or databases to log and track all information pertinent to human research protections.
Preferred Qualifications: A master's degree in research, healthcare administration or equivalent education is preferred. Knowledge of medical editing/terminology is a plus.
Licensure and Certifications: N/A
Influenza vaccination is required for all colleagues with patient contact unless medically contraindicated or due to a bona fide religious belief or practice, and is strongly encouraged for all colleagues.
Lehigh Valley Health Network is an equal opportunity employer. In accordance with, and where applicable, in addition to federal, state and local employment regulations, Lehigh Valley Health Network will provide employment opportunities to all persons without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or other such protected classes as may be defined by law. All personnel actions and programs will adhere to this policy. Personnel actions and programs include, but are not limited to recruitment, selection, hiring, transfers, promotions, terminations, compensation, benefits, educational programs and/or social activities.
Mission: We heal, comfort and care for the people of our community by providing advanced and compassionate health care of superior quality and value supported by education and clinical research.
With about 17,000 employees, Lehigh Valley Health Network (LVHN) is the region's largest employer and the health care provider of choice for more people in the region. It's also a great place to work ...because our employees have A Passion for Better Medicine. They take pride in what they do, trust one another and enjoy working alongside skilled health care professionals to continue our mission to heal, comfort and care.