CLIN RSCH SUPV 1

UCSF Health, AG; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

UCSF Health, AG seeks a capable supervisor to oversee clinical study coordination, ensuring protocol compliance for human-subject research. You will manage operational aspects, supervise staff, and collaborate with project teams across regulatory and clinical domains.

The role emphasizes experience with psychedelic trials, Parkinson’s disease populations, and regulatory submissions (IRB, FDA, RAPCal). A strong background in neuroimaging and biospecimen handling is valued in a fast-paced academic

Qualifications

• Bachelor's degree in related area.
• At least 2 years of experience working on psychedelic clinical trials (not including ketamine).
• 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: IRB, FDA, RAPCal.
• At least 1 year of experience submitting initial, modifications, and reports to the IRB, FDA, IND, and RAPCal regulatory bodies.
• At least 1 year of experience with understanding the DEA policies and guidelines for the shipment, storage, and accountability of Schedule 1 substances.
• At least 1 year of lead/supervisory experience.
• Experience with neuroimaging procedures such as MRI, PET, and TMS and demonstrated experience training others on neuroimaging techniques.
• Experience with biospecimen collection, processing, and storage for large scale clinical trials.
• Experience with overseeing recruitment efforts for psychedelic clinical trials (not including ketamine).
• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment.
• Demonstrated skills in employee supervision and HR administration.
• Demonstrated experience in training others, particularly in the field of research.
• Critical thinking skills to evaluate issues and identify a potential solution.
• Clear and concise communicator; good verbal and written communication skills; both.
• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship.
• Interpersonal skills to effectively motivate others.
• Works well with others to achieve common goals.
• Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software.
• Effectively uses campus' clinical information and documentation application programs.
• Proven ability utilizing clinical trial management systems.

Responsibilities

• Involves the development of and ensures compliance with clinical study protocols that involve human subjects.
• Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with SOPs and regulations.
• May be responsible for finances, clinical operations, and site and vendor selection.
• Provides immediate supervision to a unit or group of operational or technical employees; supervisory activities are a primary part of the job.
• Oversees staff in execution of assignments; trains and mentors staff to improve quality and quantity of work.

Skills

Clinical trial management

Regulatory reporting

Supervisory experience

Team leadership

Regulatory compliance

Communication skills

Education

Bachelor's degree in related area

Tools

IRB/FDA/RAPCal reporting tools

Clinical trial management systems

Neuroimaging data handling

EHR/clinical documentation systems

Job description

Description & Requirements

Job Description

Job Function Summary: Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams 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.

Generic Scope Provides immediate supervision to a unit or group of operational or technical employees. A portion of time may be spent performing individual tasks related to the unit; however, supervisory activities must constitute a primary part of the job. Supervises unit operations to ensure compliance with departmental or organizational policies, procedures, and defined internal controls. Ensures accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental standards and procedures.

Custom Scope Supervises staff involved in routine research study coordination. Receives predetermined work assignments that are subject to a moderate level of control and review. Oversees staff in execution of assignments; trains and mentors staff to improve quality and quantity of work.

Department Overview: The UCSF Department of Psychiatry and Behavioral Services is among the nation's foremost resources in the field of child, adolescent and adult mental health. Psychiatry faculty members are recognized for their leadership roles in state-of-the-art, comprehensive and compassionate patient care, pioneering research, excellence in training the next generation of leaders, advancing public policy to advance mental health, and commitment to diversity.

Qualifications

• Bachelor's degree in related area.
• At least 2 years of experience working on psychedelic clinical trials (not including ketamine)
• 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: IRB, FDA, RAPCal
• At least 1 year of experience submitting initial, modifications, and reports to the IRB, FDA, IND, and RAPCal regulatory bodies.
• At least 1 year of experience with understanding the DEA policies and guidelines for the shipment, storage, and accountability of Schedule 1 substances
• At least 1 year of lead/supervisory experience
• Experience with neuroimaging procedures such as MRI, PET, and TMS and demonstrated experience training others on neuroimaging techniques (ex. TMS coil holding)
• Experience with biospecimen collection, processing, and storage for large scale clinical trials
• Experience with overseeing recruitment efforts for psychedelic clinical trials (not including ketamine)
• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated skills in employee supervision and HR administration.
• Demonstrated experience in training others, particularly in the field of research
• Critical thinking skills to evaluate issues and identify a potential solution.
• Clear and concise communicator; good verbal and written communication skills; both.
• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others.
• Works well with others to achieve common goals.
• Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software.
• Effectively uses campus' clinical information and documentation application programs.
• Proven ability utilizing clinical trial management systems.

Preferred:

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