Limited Appointment Senior Clinical Research Coordinator
About The Position
This is a limited appointment ending June 30, 2027. The Senior Clinical Research Coordinator independently coordinates and is accountable for the overall administration of several clinical studies, requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel. This role may serve several divisions within the department including but not limited to: hematology, medical genetics and allergy/immunology/BMT. They may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. The Senior CRC is responsible for, and critically important to, the overall operational management of clinical research activities. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials, local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as clinical database and biorepository. Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff administration, IRB, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.
Requirements
- Advanced-level knowledge and skills in clinical research coordination
- Ability to provide leadership to lower-level clinical research coordinators and/or other support personnel
- Ability to coordinate data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies
- Ability to implement a diverse portfolio of research activities for one or more studies
- Sophisticated medical knowledge base
- Substantial leadership skills
- Effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff administration, IRB, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH)
- In-depth knowledge of specific programs
Responsibilities
- Central responsibility for ensuring IRB approval and compliance
- Budget and contract generation, negotiation and approval
- Subject recruitment
- Appropriate study testing
- Adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts
- Act as intermediary between services and departments while overseeing data and specimen management
- Manage and report on study results
- Create, clean, update, and manage databases and comprehensive datasets and reports
- Exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial, oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes
- Coordinate staff work schedules and assist the Clinical Research Supervisor and/or PI with oversight and training of other research staff
- Manage Investigator’s protocols in the IRB online system, as well as renewals and modifications of protocol applications and the implementation of new studies
- Participate in the review and writing of protocols to ensure institutional review board approval within University compliance
- Oversee study data integrity
- Implement and maintain periodic quality control procedures
- Interface with departments to obtain UCSF approval prior to study initiation
- Maintain all regulatory documents
- Report study progress to investigators
- Participate in any internal and external audits or reviews of study protocols
Benefits
- Total compensation information available at https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
