ASSOC DIR CLIN RESEARCH, AUDIT & COMPLIANCE
Duties: Provide training for the compliance team who are responsible for regulatory oversight of the clinical research at Penn; Conduct quality assessments and strategic analysis of compliance reports and ensure consistent application of regulations; Direct oversight of site compliance process reviews as a part of on-boarding or annual staff competency review; Monitor the regulatory environment for changes to regulations and/or guidance. Ensure communication of changes to OCR team and the research community. Oversee the training of all areas of compliance including IND/IDE, GCP, departmental tools, report writing and the on boarding of new hires; Identify gaps in knowledge and facilitate programs of improvement/training in compliance group and the Penn community; Provide and assist PIs and study teams in the structure, development and maintenance of clinical trials; Identify future training needs based upon trends in clinical trials, regulatory requirements, institutional policies and procedures and create methods to facilitate learning; Provide interpretation and guidance of clinical related regulations / guidelines (FDA, ICH, etc.) and University procedures to help support clinical research teams at the University of Pennsylvania.
Qualifications: Requires a MS in biomedical science, regulatory affairs, clinical research, nursing or related health sciences degree and 5-7 years of clinical trial research experience in academia or the pharmaceutical industry, including at least 3-5 years of clinical trial monitoring or auditing experience; or an equivalent combination of education and experience in compliance oversight of clinical trials (monitoring, QA or auditing), project management, or combination thereof in any of the following environments: Academia, Pharmaceutical Industry, Contract Research Organizations (academic or private) or Site Management Organization (academic or private); Development of training/educational curriculum and practices experience preferred; Previous supervisory experience preferred; Extensive knowledge of Federal Regulations and Good Clinical Practice (GCP) requirements is required; Advanced knowledge of essential documents related to clinical trials, medical terminology and routine medical tests and procedures is required; 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 to effectively and independently provide over sight and training of the compliance team;
Demonstrated diplomacy, conflict resolution and negotiation skills; 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; Adept in the use of computerized databases and other applications and in performing data analyses to evaluate trends and metrics; Proven project management skills, including effective planning and organizational skills, attention to detail and excellent follow through.
Reference Number: 40-25228
Salary Grade: 029
Employment Type: Exempt
Org: SM-DN-Office of Clinical Research
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: B-Executive/Managerial Administration