Technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas; problem-solving frequently requires analysis of unique issues / problems without precedent and / or structure. Will work closely with research leadership to manage programs that include formulating strategies and administering policies, processes, and resources; functions with a high degree of autonomy. Applies extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.
Meet with department stakeholders to support shared clinical research objectives across sub-specialty sections. Working closely with Research leadership, the position involves the development of guidelines and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with the project teams, post-award team, and in accordance with standard operating procedures and good clinical practice and regulations. May be responsible for finances, clinical operations, and site and vendor selection.
The Clinical Research Analyst 4 manages the accountability and stewardship of financial, and often physical resources in compliance with departmental and organizational goals and objectives. Manage research data functions; Supervise PRO collection and management of subject sample data and specimens with high fidelity; develop and maintain new technologies to efficiently manage data integrity for compliance.
The Clinical Research Analyst 4 will manage, train, and maintain quality control for the Department, following clinical research activities performed by Clinical Research Coordinators: recruit and screen volunteer research subjects; administrator questionnaires, retain and follow subjects with repeated center visits over several months; collect, process and ship biological samples; perform cognitive function tests; data entry and basic data analysis; preparation of data summaries and progress reports.
The CLIN RSCH ANL 4 is responsible for management of the Orthopaedic clinical research program including all site policies and procedures; management and safety of the research subjects seen at the sites; develop strategies that enhance the efficiency of clinical studies with the PIs; develop Standard Operating Procedures (SOPs) for research procedures and biosample processing; generate and lead the maintenance of compliant protocols for the Committee on Human Research at UCSF, IRB and Clinical Trials.gov; independently develop efficient processes for data management of studies conducted at the Orthopaedic Surgery sites; motivate and maintain subject compliance to remain in long-term clinical studies; and develop and maintain relationships with UCSF and non-UCSF vendors.
The final salary and offer components are subject to additional approvals based on UC policy.
To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)
Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.
For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.
To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html
- Advanced degree preferred
- Clinical Trial Professional certification from a professional society within one year in position
- Previous experience coordinating multicenter research studies
- Previous experience writing and submitting grant proposals
- Previous experience in writing and publishing research manuscripts and journal articles
- Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
- Bachelor's degree in related area and 5 (five) or more years of relevant experience and / or equivalent experience / training
- 1 or more years of supervisory experience
- Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory and financial requirements
- In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems
- Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator
- Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals
- Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems
- In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team
- Clinical research experience, including recruitment of research subjects and/or PROs
