Clinical Research Supervisor I

University of California, San Francisco•San Francisco, CA

About The Position

The Clinical Research Supervisor I supervises staff involved in routine research study coordination and oversees operational aspects of clinical studies or trials involving human subjects. The role ensures compliance with study protocols, standard operating procedures, good clinical practice, regulations, and organizational policies. The supervisor manages staff assignments and performance, trains and mentors employees, supports study initiation and coordination, and oversees data collection, regulatory documentation, auditing, research billing, and sample management. The position also contributes to personnel decisions, recruitment, and employee orientation.

Requirements

Working knowledge of clinical or laboratory research, clinical-trial recruitment and eligibility, protocol adherence, quality data submission, and adverse-event reporting.
Ability to manage multiple priorities, prioritize projects, and meet demands in a fast-paced, dynamic work environment.
Adaptability to quickly changing priorities.
Demonstrated skills in employee supervision and human resources administration.
Demonstrated experience training others, particularly in research.
Critical-thinking skills to evaluate issues and identify potential solutions.
Clear, concise verbal and written communication skills.
Interpersonal skills, including problem-solving, teamwork development, leadership, and mentorship.
Ability to motivate others and work collaboratively toward common goals.
Ability to cultivate relationships with stakeholders at various administrative levels.
Ability to perform commonly applicable functions in word-processing and spreadsheet software.
Effective use of campus clinical information and documentation applications.
Proven ability to use clinical trial management systems.

Responsibilities

Distributes work and monitors the progress, quality, and quantity of assigned staff members’ work.
Researches and resolves work issues and discrepancies, and reports staff performance evaluations and work effort to management.
Ensures staff follow internal policies, processes, and research compliance requirements.
Trains employees on research regulatory processes, database entry, participant-family interactions, source documentation, adverse-event reporting, and protocol adherence.
Implements and maintains research study processes and serves as a liaison between staff and program leaders.
Promotes communication and teamwork among cross-functional research teams.
Initiates clinical trial studies and oversees study coordination, including development of systems and forms for research billing, recruitment packets, and calendars.
Reviews patient accrual and eligibility for clinical trials to support human-subject protection and quality recruitment.
Coordinates multiple studies and priorities to support smooth operations and patient safety.
Supervises the timeliness and quality of data collection, submission, and completion.
Monitors and audits study visits and oversees preparation for audits; attends auditor meetings and helps staff monitor site compliance.
Ensures data and regulatory documentation are sufficient and up to date, and uses computer applications to generate reports and support data-entry quality assurance.
Tracks patient charges, identifies billable triggers, supports clinical-trial budget preparation, trains coordinators on research billing, and works with billing to resolve disputed charges.
Oversees data interpreted from samples and its entry and review in databases, and ensures sample integrity and security.
Recommends salary actions, promotions, terminations, and other personnel-related actions.
Participates in recruitment and orientation of new employees, evaluates staff performance, and provides guidance and mentorship.