CLIN RSCH SUPV 1

UCSF•San Francisco, CA

1d•$94,300 - $150,000

About The Position

The Clinical Research Supervisor 1 supervises staff involved in routine research study coordination and oversees operational aspects of clinical studies and trials involving human subjects. The role ensures compliance with study protocols, standard operating procedures, good clinical practice, regulations, and organizational policies. The supervisor oversees staff assignments, trains and mentors employees, supports research operations, and may contribute to study finances, clinical operations, and site and vendor selection. In the UCSF Department of Psychiatry and Behavioral Services, the position supports clinical research within a department focused on child, adolescent, and adult mental health. The supervisor coordinates clinical trial initiation and operations, recruitment and eligibility, patient safety, data collection and reporting, audit preparation, research billing, and the handling and documentation of samples. The role also participates in personnel actions, recruitment, and employee orientation.

Requirements

Bachelor's degree in a related area.
At least 2 years of experience working on psychedelic clinical trials, excluding ketamine trials.
At least 2 years of experience working with the Parkinson’s disease population.
At least 2 years of experience reporting to regulatory bodies for Schedule 1 research, including IRB, FDA, and RAPCal.
At least 1 year of experience submitting initial applications, modifications, and reports to IRB, FDA, IND, and RAPCal regulatory bodies.
At least 1 year of experience understanding DEA policies and guidelines for shipment, storage, and accountability of Schedule 1 substances.
At least 1 year of lead or supervisory experience.
Experience with neuroimaging procedures such as MRI, PET, and TMS, including demonstrated experience training others on neuroimaging techniques such as TMS coil holding.
Experience with biospecimen collection, processing, and storage for large-scale clinical trials.
Experience overseeing recruitment efforts for psychedelic clinical trials, excluding ketamine trials.
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, meet demands in a fast-paced and dynamic work environment, and adapt to changing priorities.
Demonstrated employee supervision and HR administration skills, and 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 in problem-solving, teamwork development, leadership, mentorship, and motivating others; ability to work with others toward common goals and cultivate relationships with stakeholders at varying administrative levels.
Ability to perform commonly applicable functions in word-processing and spreadsheet software and effectively use campus clinical information and documentation applications.
Proven ability to use clinical-trial management systems.

Nice To Haves

Advanced degree.
Clinical Trial Professional certification from a professional society within one year in the position.

Responsibilities

Distribute work, monitor assigned staff’s progress, resolve issues and discrepancies, assess the quality and quantity of work, and report performance evaluations to management.
Ensure staff follow internal policies and processes; train employees on regulatory processes, database entry, and working with participant families; and implement and maintain research study processes.
Serve as a liaison between staff and program leaders, report work effort to the department, and foster communication and teamwork across research teams.
Initiate clinical trial studies; oversee and review studies; develop systems and forms for research billing, recruitment packets, and calendars; and review patient accrual and eligibility for compliance and quality recruitment.
Coordinate studies by multitasking and prioritizing while ensuring patient safety and human-subject protections.
Supervise timely, high-quality data collection, submission, and completion; train study coordinators on source documentation; and create forms for adverse-event reporting and protocol adherence.
Monitor and audit study visits; oversee audit preparation; ensure data and regulatory documentation are sufficient and up to date; use computer applications for reports and data-entry quality assurance; attend auditor meetings; and assist staff with monitoring site compliance.
Track patient charges, alert the department to billable triggers, support clinical-trial budget preparation, train coordinators on research billing, and coordinate with billing to resolve disputed charges.
Oversee incoming sample data, ensure it is correctly entered and reviewed in databases, and maintain sample integrity and security.
Recommend salary actions, promotions, terminations, and other personnel actions; participate in recruiting and orienting new employees.