CLIN RES REGULATORY COMPLIANCE SPECIALIST
Duties: The Clinical Research Compliance Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Director of Compliance of the OCR. Under the management of the Director of Compliance, the candidate will work as part of the Compliance team to help support and facilitate clinical research at the University of Pennsylvania. The candidate will work with senior team members to plan, schedule and conduct reviews of Penn Faculty or University held IND/IDE's with the intent to perform independently. Reviews will assess whether all aspects of the clinical investigation and internal processes are in compliance with applicable federal and local regulations, regulatory requirements and established University of Pennsylvania policies and procedures.
This position will interface with the Perelman School of Medicine faculty and staff, institutional offices, clinical departments and research institutes. Within the OCR, the Clinical Research Compliance Specialist will interface with other OCR Divisions to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives and to participate in research staff training. The candidate is also responsible for mentoring junior staff members within the compliance team.
Qualifications: * Minimum level of education and experience equivalent to a Bachelor's degree(preferably in Biomedical science, nursing or related health sciences) and three to five years work experience in compliance oversight of clinical trials (monitoring, QA or auditing), study coordinator, project management, or combination thereof in any of the following areas: Academia, Pharmaceutical Industry, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private) required.
* Knowledge and experience in the application of Good Clinical Practice (GCP) requirements is desired (e.g., ICH, FDA, etc.). Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is preferred.
* Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines
* Ability to respect and protect highly sensitive and confidential information
* The candidate must possess strong interpersonal, oral and written communication skills in order to effectively and independently conduct regulatory compliance reviews and communicate findings.
* Strong ability to demonstrate diplomacy and negotiation skills, as well as the ability to persuade when necessary. Able to confidently interact with all levels of management including senior management, PI's and others.
* The ability to develop interdepartmental relationships and form solid collaborations.
* Strong sense of urgency in escalating non-compliance issues.
* Adept in the use of computerized databases and other applications and in performing data analyses to evaluate trends and metrics.
* The candidate must be able to assimilate large amounts of data efficiently, exercise sound judgment and maintain composure in order to effectively handle sensitive issues, such as instances of serious clinical noncompliance.
* Proven project management skills, including effective planning and organizational skills, attention to detail and excellent follow through.
Reference Number: 40-27940
Salary Grade: 027
Employment Type: Exempt
Org: SM-DN-Office of Clinical Research
Job Family: I-Technical/Professional Research