Clin Rsch Supv 1

University of California, San Francisco•San Francisco, CA

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. The role ensures that studies are conducted in accordance with protocols, standard operating procedures, good clinical practice, and applicable regulations. The supervisor oversees staff assignments, quality and timeliness of work, training, research processes, regulatory compliance, data collection, recruitment, study billing, and sample integrity. The position also supports clinical trial initiation and audit preparation, and makes recommendations concerning personnel actions. The UCSF Department of Psychiatry and Behavioral Services is a leading resource in child, adolescent, and adult mental health, with commitments to comprehensive patient care, pioneering research, training, public policy, and diversity.

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 I research: IRB, FDA, and RAPCal.
At least 1 year of experience submitting initial applications, modifications, and reports to the 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 I 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, and meet demands in a fast-paced, dynamic work environment; adaptable to changing priorities.
Demonstrated skills in employee supervision and HR 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, mentorship, and motivating others.
Ability to work collaboratively toward common goals and cultivate relationships with stakeholders at multiple administrative levels.
Ability to perform commonly applicable functions in word-processing and spreadsheet software.
Ability to 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 and monitor assigned staff's progress, quality, and quantity of work; address issues and discrepancies and report performance evaluations and work effort to management.
Supervise staff to ensure compliance with departmental policies and research requirements; train and mentor employees on regulatory processes, database entry, participant-family interactions, and research procedures.
Implement and maintain research study processes, and serve as a liaison between staff and program leaders while promoting communication and teamwork across research teams.
Initiate clinical trials; oversee studies and help develop systems, forms, recruitment packets, calendars, and research billing processes.
Review patient accrual and eligibility for clinical trials to support human-subject protections and quality recruitment; coordinate studies and prioritize work to support patient safety.
Oversee the timeliness and quality of data collection, submission, and completion; train coordinators in source documentation, adverse-event reporting, and protocol adherence.
Monitor and audit study visits, oversee audit preparation, ensure data and regulatory documentation are current and sufficient, and attend auditor meetings.
Use computer applications to generate reports and conduct quality assurance of required data entry; 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 data received from samples to ensure accurate database entry and review, and maintain sample integrity and security.
Recommend salary actions, promotions, terminations, and other personnel actions; participate in recruiting and orienting new employees.