Clinical Research Operations Manager

2 weeks ago


Salt Lake, Utah, United States University of Utah Full time
Position Overview:
As a key member of the University of Utah's Pediatric Hematology-Oncology Division, the Clinical Research Operations Manager plays a pivotal role in overseeing the Research Enterprise team. This team is responsible for managing a variety of clinical trials, including those sponsored by the Children's Oncology Group (COG) and other industry/governmental entities focused on pediatric cancer.

Work Schedule:
This is a full-time position requiring 40 hours per week, typically Monday through Friday, with occasional evening and weekend commitments.

Key Responsibilities:
1. Lead the planning, organization, and management of all research-related functions.
2. Supervise and evaluate research support personnel, ensuring high-quality research efforts.
3. Collaborate with Principal Investigators and senior management to maintain research quality across the division.
4. Develop and implement strategies for integrating new studies into the existing research portfolio.
5. Ensure compliance with regulatory requirements and institutional policies.

Team Management:
The Clinical Research Operations Manager will oversee the daily operations of the research team, which includes Research Coordinators, Regulatory Coordinators, and Research Assistants. Responsibilities include:
- Assigning and distributing workloads for incoming clinical studies.
- Monitoring enrollment and participant compliance across all studies.
- Conducting performance evaluations and training programs to enhance staff competencies.

Quality Assurance:
Ensure that all research activities adhere to Good Clinical Practice (GCP), HIPAA, and FDA regulations. This includes:
- Developing standard operating procedures to maintain consistent quality.
- Organizing weekly team meetings to discuss project updates and challenges.
- Identifying budgetary issues and proposing solutions to ensure project adherence to financial guidelines.

Qualifications:
- A Bachelor's degree in a relevant field or equivalent experience.
- A minimum of four to six years of progressively responsible management experience in clinical research.
- Strong leadership skills and the ability to effectively communicate with diverse teams.

Work Environment:
This position is primarily office-based, requiring strong attention to detail and the ability to manage multiple priorities effectively. The University of Utah values diversity and encourages candidates from all backgrounds to apply.

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