University of California , San Francisco
Sr. Crc
San Francisco, California · Senior
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About the role
- Description Senior Clinical Research Coordinators independently coordinate and are accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills.
- The position is responsible for, and critically important to the overall operational management of clinical research activities.
- 100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9.
Responsibilities
- Develop project plans, interview key sponsors, and deliver tangible project results
- Design and perform ad-hoc performance analysis of the projects and the project staff
- Perform business process review, operational reviews and design and implement workflow and controls
- Develop project-related presentation material for study
- Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-trial agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance.
- Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects' options, and ensure that documentation and storage of study files meets legal requirements.
- Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all CHR documents are up to date.
- Manage infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation; work with leadership to ensure proper execution of studies.
- Manage activities for cohorts in various areas of studies and disciplines; and for clinical trials in various disciplines.
- Collaborate with other Universities, clinical entities, and industry using collected data to understand disease progression and predictors.
Requirements
- Bachelor's degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training.
- In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
- knowledge of strategies for recruiting human subjects.
- Ability to analyze complex and non-routine issues requiring innovative solutions.
- Ability to operate effectively in a changing organizational and technological environment.
- Ability to assess and respond to audit risk
- Ability to interpret and apply policies and regulations.
- Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
- Experience using database software, such as MS Access or FileMaker Pro.
- Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire.
Nice to have
- Fluency in spreadsheet software
- demonstrated skills in audit preparation, execution, and follow-up.
- Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
- Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
Benefits
- Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects
This listing is sourced directly from University of California , San Francisco's careers page and normalized into a canonical job model.