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Director of Clinical Research Operations
4 weeks ago
Job Summary:
The Director of Clinical Research Operations will oversee the operational aspects of clinical research within the Department of Dermatology, ensuring alignment with the University of Pennsylvania, GCP, FDA, and all applicable regulatory bodies. The ideal candidate will have a comprehensive understanding of clinical trial processes and the conduct of clinical research studies.
Key Responsibilities:
- Lead the day-to-day operations of the clinical research team, including managing staff, coordinating research studies, and ensuring compliance with regulatory requirements.
- Collaborate with principal investigators, research staff, and other stakeholders to identify resource needs, forecast logistical issues, and ensure smooth transition of protocols from startup to study activation and close-out.
- Develop and implement operational process improvements, tools, and quality systems to ensure adherence to standard operating procedures (SOPs), GCP, and regulatory requirements.
- Manage the Clinical Trial Management System (Penn CTMS) for all studies conducted within the department, develop and monitor program metrics, and remain engaged in organizational goals.
- Lead research team meetings, oversee protocol training and compliance meetings, and serve as the primary operations liaison for internal collaborative departments.
Qualifications:
Bachelor's degree and 7-10 years of related experience required; Master's degree and 5-7 years of related experience preferred.
- Training and experience in clinical research or clinical research compliance healthcare required.
- At least 5 years' experience in a hospital academic medical setting or pharma with principal responsibilities related to clinical research and/or research education preferred.
- Able to confidently interact with all levels of management, including senior management, physician leaders, and others.
- Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans.
- Must be detail-oriented and organized.
- Excellent verbal/written communication skills required.
- Must be a demonstrated initiative-taker and team player with strong interpersonal skills.
- Prior experience in developing policy or procedural documentation and/or guidance documents is desired.
- Excellent technical writing, review, and analytical and problem-solving abilities; excellent interpersonal and multi-tasking skills.
- Ability to work collaboratively on all levels and to gain support from others.
- 5+ years of Good Clinical Practices (GCP) related experience required; thorough knowledge of relevant regulations for the conduct of clinical trials, including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines.
- Knowledge of funding policies, NIH, and other grant procedures is desired.
- Strong MS Office skills.
Benefits:
- Competitive salary range: $140,000.00 - $170,000.00 Annual Rate
- Excellent benefits package, including health, life, and flexible spending accounts, tuition assistance, retirement plans, and more.
How to Apply:
Please visit https://www.hr.upenn.edu/PennHR/benefits-pay to learn more about the benefits and pay for this position.
