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About the Role
This role involves the development of and ensures compliance with clinical study protocols that involve human subjects. It 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. The position may be responsible for finances, clinical operations, and site and vendor selection.
Responsibilities
- Distributes work.
- Monitors the progress of work of assigned staff.
- Researches and resolves issues and discrepancies.
- Manages subordinates' quality and quantity of work to ensure unit meets its objectives.
- Reports performance evaluation to management.
- Follows internal policies and processes.
- Supervises assigned staff to ensure compliance.
- Trains employees on research regulatory processes, database entry, and working with participant families.
- Implements and maintains defined research study processes.
- Serves as a liaison between staff and program leaders.
- Reports work effort to the department.
- Cultivates communication and teamwork between cross-functional teams working on research.
- Initiates a clinical trial study.
- Oversees and reviews study and helps create systems and forms to ensure research billing, packets for recruitment and calendars are developed.
- Reviews accrual and eligibility for each patient placed on a clinical trial to ensure human subject protection regulations are in compliance and quality recruitment.
- Multi-tasks and prioritizes to smoothly coordinate studies and ensure patient safety.
- Supervises the timeliness and quality of data collection, submission and completion.
- Trains new study coordinators in collecting and understanding source documentation.
- Creates forms for ensuring proper reporting of adverse events and protocol adherence to federal regulations.
- Monitors and audits visits.
- Monitors preparation in order to oversee and assist study coordinators in preparing for audits.
- Ensures data is sufficient and updated, including all regulatory documentation.
- Uses computer applications to generate reports and quality assurance of required data entry.
- Attends all meetings with auditors.
- Assists staff assigned with monitoring site compliance.
- Tracks patient charges and alerts the department on billable triggers to collect money.
- Understands budget preparation for clinical trials; interprets and trains the study coordinators on how to proceed in proper data research billing.
- Coordinates with billing to resolve disputed charges.
- Oversees the incoming data interpreted from samples and ensures that it is correctly entered into respective databases, and reviewed.
- Ensures integrity and security of samples.
- Recommends salary actions, promotions, and terminations.
- Recommends personnel-related actions.
- Participates in the recruitment and orientation of new employees.
Requirements
- 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.
- Advanced degree preferred.
- Clinical Trial Professional certification from a professional society within one year in position.
Skills
- Research regulatory processes
- Database entry
- Working with participant families
- Research billing
- Patient safety
- Data collection
- Data submission
- Adverse event reporting
- Protocol adherence
- Federal regulations
- Audits
- Regulatory documentation
- Computer applications
- Report generation
- Quality assurance
- Data entry
- Budget preparation
- Data research billing
- Sample data interpretation
- Database management
- Sample integrity
- Sample security
- Neuroimaging procedures
- MRI
- PET
- TMS
- Neuroimaging techniques
- Biospecimen collection
- Biospecimen processing
- Biospecimen storage
- Clinical trial management systems
- Word processing software
- Spreadsheet software
- Clinical information application programs
- Documentation application programs
Experience Level
- Lead/supervisory experience
Education Level
- Bachelor's degree
- Advanced degree
About the Company
- 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.