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Clinical Research Operations Manager
1 month ago
At Unavailable, we are committed to advancing medical knowledge and improving patient care through comprehensive clinical research services. Our team is dedicated to providing start-to-finish research support, from initiation to completion, ensuring the highest quality and compliance with regulatory guidelines.
The CommonSpirit Health Research Institute, a beacon of medical advancement, offers a wide range of clinical research services, including multi-site clinical trials, data research, and partnerships with industry and academia. As a key member of our team, you will play a pivotal role in advancing medical knowledge and improving patient care.
As a Clinical Research Operations Manager, you will provide local leadership and day-to-day supervision for all clinical trials, research activities, and site-based clinical research staff within your assigned regional research sites. You will work closely with essential research constituencies, including Investigators, research staff, and other internal and external research-related parties, to ensure the efficient and compliant initiation, ongoing administrative management, and support of research.
Key Responsibilities:
- Liaison and Guidance: Serve as a central point of contact for the research community and guide research initiation and conduct.
- Local Support: Generate local support for research activities, including maintaining visibility with local leaders, physicians, and patients.
- Site Operations Management: Ensure adherence to GCP guidelines, site timelines, quality control, data collection, drug/device management, and staff training.
- Resource Management: Monitor staff productivity, clinical trial enrollment, and resource allocation within budget targets.
- Data Management: Ensure timely data entry and tracking via CTMS and other research tracking technology.
- Quality Assurance: Promote a culture of accountability for quality assurance and improvement within the research function.
- Training and Development: Develop and implement training materials for site teams.
- Standardization and Centralization: Support standardization of regional research operations and centralize core research support services.
- Strategic Planning: Participate in CSHRI research operations oversight and strategic planning activities.
Qualifications:
Required Education and Experience:
Education: Bachelor's degree required.
Licenses & Certifications: SOCRA or ACRP certification required, or eligibility to become certified within one year of hire.
Experience & Knowledge:
- Bachelor's degree in life sciences or a related field required. Master's degree preferred.
- Minimum five (5) years of full-time experience in clinical trial management in a hospital, clinic, or physician office setting required. Experience managing clinical trials within an integrated health system preferred.
- Minimum three (3) years' experience managing and supervising research staff (e.g., clinical coordinators and regulatory staff) or 5 years leadership experience in the discipline or Master's Degree.
