Clinical Research Coordinator

University of California, San Francisco•San Francisco, CA

19d

About The Position

The Clinical Research Coordinator supports the management and coordination of one or more clinical research studies, depending on their size and complexity. The role coordinates study activities across services and departments; oversees participant, data, and specimen management; reports study progress and results; and maintains databases, datasets, reports, and regulatory documentation. The coordinator also helps schedule and train staff, supports oversight of research team members, and works with investigators and the Clinical Research Supervisor to implement studies and maintain protocol compliance. The position recruits, screens, enrolls, and retains study participants; obtains informed consent; schedules and conducts study visits; collects clinical data and biological samples; and helps ensure participant safety and adherence to study protocols. It manages study databases and data quality, supports analysis and reporting, coordinates specimen handling and shipment, and maintains participant tracking systems. The role also prepares and updates protocol and institutional review submissions, works with the Committee on Human Research and other university departments, supports audits, and helps ensure compliance with applicable regulations and institutional requirements.

Requirements

High school degree or equivalent, plus sufficient experience and demonstrated skills to perform the assigned duties and responsibilities, or equivalent experience and training.
Attention to detail, strong interpersonal skills, and effective verbal and written communication skills for coordinating with participants, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment while working with a diverse participant population.
Ability to work independently, complete projects on time, prioritize multiple projects, and meet deadlines.
Excellent presentation, organizational, and interpersonal skills, including the ability to work effectively in a diverse team.
Proficiency with Microsoft Word, Excel, PowerPoint, and Windows.
Excellent analytical and problem-solving skills.
Project management and coordination skills, including the ability to prioritize tasks and meet multiple deadlines on concurrent projects.
Ability to establish cooperative working relationships with patients, coworkers, and physicians.
Experience with geriatric, medical, or public health patient populations.
Supervised experience and proficiency screening older adults for neuroimaging safety standards.
Basic knowledge and proficiency in social science research design and statistical analyses.
Supervised experience and demonstrated proficiency conducting research interviews with structured psychiatric instruments and disability measures in older adult populations.
Supervised experience and demonstrated proficiency administering neuropsychological tests to older adult psychiatric populations.
Recruitment experience and proficiency with older adult psychiatric patient populations.

Nice To Haves

Bachelor’s degree in Psychology or Neuroscience.
Fluency using the Committee of Human Research (CHR) online iMEDris system to submit, renew, and modify protocols.
Understanding of the participant population sufficient to build rapport and assess realistic and appropriate participation.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
Experience with electronic medical records.
Knowledge of UCSF and departmental policies for reimbursement, research, confidentiality, HIPAA, patient safety, and protection of electronic and paper medical records and communications.
Knowledge of medical terminology, research policies and guidelines, infectious-substance packing and shipping guidelines, database building and analysis, and data management using tools such as Access, Stata, SAS/SPSS, and Teleform.
Demonstrated proficiency with medical terminology.
Experience working with patients or study subjects.
Prior experience using neuropsychological, psychological, and disability measures with older adults.
Knowledge of and prior experience with mental health issues in older adults.
Knowledge of local mental health facilities and resources.
Knowledge of relevant literature concerning older adults, Hoarding Disorder, and Late Life Depression.
Clinical education or experience.
Experience with the SPSS statistical package.
Experience with EndNote.
Knowledge of statistics.
Experience scheduling neuroimaging scans and neuroimaging protocols.
Experience applying Good Clinical Practice Guidelines, HIPAA, The Protection of Human Research Subjects, CHR regulations for recruitment and consent, Effective Cash Handling Procedures, Environmental Health and Safety Training, and Fire Safety Training.

Responsibilities

Identify, recruit, screen, enroll, and retain study participants, including developing recruitment and retention strategies.
Schedule study visits and follow-up appointments; administer questionnaires, collect medical history, and perform study procedures.
Obtain informed consent, review study information with participants, and advocate for participant safety throughout protocol procedures.
Maintain rapport with participants, respond to their needs, and coordinate continuity of care with providers as appropriate.
Oversee participant reimbursement and help resolve discrepancies or related issues.
Coordinate staff and study activities to ensure procedures are completed, required data are collected, specimens are stored correctly, and shipping and labeling requirements are followed.
Coordinate with other studies, technicians, collaborating groups, investigators, and departments to support scheduling and study operations.
Review medical charts and electronic records to extract information for research studies.
Collect and enter data from visits, procedures, laboratory tests, and other study participation into databases in a timely manner.
Manage and update study databases, create databases as needed, maintain data collection forms and comprehensive datasets, and perform database queries and analyses.
Work with the Supervisor to maintain complete and accurate study data and analyze data as it becomes available.
Attend and actively participate in team meetings; help train staff and team members on protocols, procedures, data collection and entry, database processes, chart review, and related work.
Oversee data integrity and assess policies and procedures for recruitment, data collection, and data management.
Maintain procedure manuals and implement periodic quality-control procedures to support consistency and data quality.
Suggest administrative infrastructure changes to accommodate study complexity; modify data collection instruments; coordinate staff schedules; and maintain participant tracking systems.
Arrange the exchange and transport of specimens with collaborating investigators and staff; ensure specimen integrity and security and appropriate use of sample-derived data.
Enter and maintain existing and new protocols in the Committee on Human Research online system; communicate with CHR Analysts as needed.
Design and improve case report forms and data collection forms, provide manuscript feedback, and maintain systems for protocol adherence and data quality.
Participate in reviewing and writing protocols and related procedures to support institutional review board approval and university compliance.
Renew, modify, and submit CHR applications and protocols on time; track approval status and liaise between CHR and study investigators.
Conduct quality-assurance checks, evaluate protocols on an ongoing basis, and implement improvements or identify applications requiring modification.
Ensure studies comply with the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Obtain UCSF departmental approvals before study initiation; maintain regulatory documents, monitor data-submission timelines, and document and report adverse events to appropriate departments.
Maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
Participate in and cooperate with internal and external audits or protocol reviews and prepare required documentation.
Perform other duties as assigned.