DIRECTOR, CLINICAL RES. OPS. TRANSLATIONAL MED.
Duties: The Director of Clinical Research Operations implements and oversees operational aspects of research within the School of Dental Medicine at the University of Pennsylvania. The Director provides regulatory guidance and clinical research support to a diverse group of investigators ensuring compliance with investigator initiated, as well as, sponsored projects (federal and non-federal). This position serves as a Senior Administrative liaison between investigators, clinical research projects and clinical research support staff.
The Director provides advice, counsel and strategic direction to senior research administration and institutional officials. They support and encouraging new and ongoing clinical research programs. In addition, they raise the level of awareness of the strategic and economic importance of clinical research to internal and external customers. The Director will interface leaders and administrators at multiple sites to assist with the expansion of the breadth of clinical research across Penn, enhancing the brand of its world-class clinical research program
Qualifications: MS with at least 5 to 7 years of experience in clinical research related activities (e.g., monitor, study coordinator, or similar experience).
An in-depth knowledge and experience in the application of Good Clinical Practice (GCP) regulations is required (e.g., ICH, FDA, NIH/NCI, 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 needed.
Strong interpersonal, oral and written communication skills in order to effectively and independently oversee clinical operations and communicate results.
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.
Ability to develop interdepartmental relationships and form solid collaborations is critical.
Adept in the use of computerized databases and other applications and in performing data analyses to evaluate trends and metrics.
The ideal candidate has experience with grants, subcontracts, industry partnerships, alternative funding streams, technology transfer, and intellectual property rights, along with research faculty/staff interaction and management.
Reference Number: 51-30468
Salary Grade: 030
Employment Type: Exempt
Org: Clinical Affairs
Job Family: B-Executive/Managerial Administration