Research Compliance Specialist

Job Details Conducts research compliance tasks and initiatives such as: conducting risk assessments of various research functions, monitoring and auditing research. Conducts education and training on research related activities, regulatory change, and policies and procedures.

• Conducts routine and for-cause compliance audits to ensure accuracy, privacy, and security of participant information and compliance with all protocols and relevant policies and maintains all audit records and findings.
• Prepares audit reports to present to research investigators; reviews/assists in the development of research corrective and preventative action plans (CAPA), as needed.
• Reviews and manages research-related compliance matters, allegations of research noncompliance, research protocol deviations, conflicts of interest related to research, and allegations of research misconduct; maintains all research compliance case records.
• Assembles case documents and supportive information to present to the Research Compliance Committee (RCC) and Research Conflict of Interest Committee (COIC); writes and processes the letters of determination and management plans.
• Manages a tracking system to record research conflict of interest (COI) disclosures and serves as a resource to Investigators and researchers in completing their COI Questionnaire.
• Conducts research training for all new investigators and research staff to understand processes on informed consent, regulatory, source documentation, etc. Provides education on research compliance policies, guidelines, and procedures, as needed.
• Understands and remains current on relevant law, guidelines, and institutional policies to protect human subjects and ensures institutional compliance. Demonstrates knowledge of FDA, OHRP, DHHS, GCP, Office of Research Integrity (ORI), and other regulatory agency requirements related to human subject clinical research, identifies areas of focus for quality improvement (using FDA and GCP guidelines), and ensures assures reviews are conducted in accordance with regulatory and AAHRPP requirements. Education - Required
• Bachelor’s Degree Education - Preferred
• Bachelor’s Degree in nursing or
• Bachelor’s Degree health related field Experience - Required
• 2 years of experience in a clinical research environment Knowledge, Skills and Abilities - Required
• Ability to work with personnel at all levels to gather information, communicate compliance requirements, and handle complex issues.
• Knowledge of regulations regarding the use of human subjects in clinical trials, outcomes research, nursing research, and other research areas.
• Strong attention to detail and ability to adhere to policies and procedures. Work Shift Worker Sub Type Regular Employee Entity Primary Location Address , , , Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health , nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa­tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps ), have access to medical (including prescription) insurance. For more benefits information, please click here