Clinical Research Supervisor

University of California, San Francisco; San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

University of California, San Francisco is seeking an Advanced Lung Disease Clinical Research Supervisor to oversee the operational management of the ILD clinical research portfolio, including multicenter NIH and industry trials, investigator-initiated studies, and biorepository efforts.

Reporting to the ILD Program Directors, the role ensures compliance, enrollment, data integrity, and contract management across complex trials and collaborations.

Qualifications

• Bachelor’s degree in related field and five+ years of experience including three+ years supervisory.
• At least 3 years in clinical trial management with regulatory/compliance experience.
• 3–5 years in lead/supervisory role.
• Clinical Trial Professional certification within one year.
• Experience as a project manager and ability to develop plans/schedules.
• Audits: preparation, execution, follow-up.
• Experience with UCSF grant procedures, personnel docs and contracts.
• Ability to develop recruitment strategies for complex patient pools.
• Knowledge of clinical research contracts, grants, FDA regulations and visit structures.
• Project management for HR and financial analysis.
• Fluency with spreadsheet software and complex spreadsheets.
• HR management knowledge.
• Experience in risk management with sponsors and regulators.
• Ability to analyze complex issues and adapt to change.
• Ability to interpret policies and regulations.

Responsibilities

• Lead the administration and management of the clinical trials program.
• Ensure program compliance, safety, supervision, and financial oversight.
• Oversee approval, contracts, recruitment, testing, and enrollment for multicenter trials.
• Coordinate with CHR approval and contract generation and negotiation.
• Develop recruitment strategies and monitor progress against goals.

Skills

Project management

Recruitment strategy

Budgeting & financial analysis

Audit & compliance

HR management

Regulatory knowledge

Data handling (MS Access/Filemaker)

Team leadership

Problem solving

Education

Bachelor’s degree in related field

Master’s degree (preferred)

Tools

MS Access

Filemaker Pro

Job description

Job Description

Job Summary: The position of Advanced Lung Disease Clinical Research Supervisor is responsible for the overall operational management of the UCSF Advanced Lung Disease Program’s clinical research activities. Both of these programs are growing substantially and have significant management responsibilities. This position is critically important to the management of the increased clinical research activities.

The position of Advanced Lung Disease Clinical Research Supervisor involves direct responsibility for implementing a diverse portfolio of research activities including multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and programmatic clinical research activities such as the clinical database and biorepository. The Clinical Research Supervisor is a critical position that requires expert and efficient integration of multiple complex programmatic activities.

Under the direction of the Director, ILD Program and the Director of Clinical Trials, ILD Program, the Clinical Research Supervisor will have central responsibility for ensuring CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of all multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts.

Responsibilities

The Advanced Lung Disease Programs need strong administrative and management leadership, strong research coordination, and experienced personnel who can ensure optimal efficiency, compliance, safety, employee supervision and management, financial oversight, and contractual expertise. The Clinical Research Supervisor’s main purpose is to ensure that the programs’ clinical research commitments are met and that the program maintains excellence in all its activities.

Required Qualifications

• Bachelor’s degree in related field and five or more years of related experience which includes three or more years of supervisory experience and/or an equivalent combination of education and experience.
• At least 3 years’ experience in clinical trial management or equivalent years progressively responsible experience in a related position including regulatory and compliance responsibilities.
• Three to 5 years in a Lead or Supervisory role.
• Clinical Trial Professional certification from a professional society within one year in position.
• Experience serving as a project manager and the ability to develop project plans and schedules and to motivate team members to complete objectives within deadlines.
• Demonstrated experience in audit preparation, execution, and follow-up.
• Experience using database software, such as MS Access or Filemaker Pro.
• Experience with UCSF grant application procedures, personnel documentation and contracts generation, and CARE and UCSF subcontracting.
• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies and continually adjusting strategies to meet recruitment goals as needed.
• In-depth and extensive knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee the administrative operations of the clinical trials program. Specifically, must have knowledge of strategies for recruiting human subjects to research studies as well as skills for HR management and financial analysis.
• Demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
• Fluency in spreadsheet software and the ability to develop independently complex spreadsheets.
• A well-rounded knowledge of human resource management.
• Previous experience in risk management regarding complicated study subjects, and federal and non-federal sponsors and regulating bodies.
• 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.

Preferred Qualifications

• Master’s degree related to scientific/medical area.
• Certified Clinical Research Coordinator.

License/Certification

• Clinical Trial Professional certification from a professional society within one year in position.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

To learn more about the benefits of working at UCSF, including total compensation, please visit: UCSF Compensation & Benefits.