Clinical Research Coordinator

UCSF•San Francisco, CA

21d•$40 - $47

About The Position

The Clinical Research Coordinator supports and coordinates one or more clinical research studies, depending on their size and complexity. The role coordinates study activities across services and departments; manages study data, specimens, databases, and reports; and supports investigators and research staff with study oversight, scheduling, training, and reporting. The coordinator also recruits, screens, enrolls, schedules, and retains participants; collects clinical data and biological samples; and ensures participants are evaluated according to study protocols. The position is responsible for protocol and regulatory administration, including entering and maintaining protocols in the Committee on Human Research (CHR) online system, preparing renewals and modifications, supporting institutional review board approval, obtaining UCSF approvals before study initiation, and maintaining regulatory documentation. The coordinator helps ensure compliance with applicable regulations and institutional requirements, safeguards data and sample integrity, implements quality-control procedures, and participates in audits and protocol reviews. The role also supports data analysis, reporting, research-team training, and continuous improvement of study processes.

Requirements

High school degree or equivalent, and sufficient experience and demonstrated skills to perform the assigned duties and responsibilities; equivalent experience or training may also qualify.
Attention to detail; strong interpersonal skills; and excellent verbal and written communication skills for coordinating with subjects, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment while working with a diverse subject population.
Ability to work independently, complete projects on time, and prioritize multiple projects and deadlines.
Excellent presentation, organizational, and interpersonal skills for working 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, and supervised experience screening older adults for neuroimaging safety standards.
Basic knowledge and proficiency in social science research design and statistical analyses.
Supervised experience conducting research interviews with structured psychiatric instruments and disability measures in older adult populations.
Supervised experience administering neuropsychological tests with 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 with the CHR online iMEDris system for protocol submissions, renewals, and modifications.
Understanding of the patient population and ability to build rapport while judging what is realistic and appropriate for patient 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 concerning reimbursement, research, confidentiality, HIPAA, patient safety, and medical records; knowledge of the UCSF mission and research purpose.
Knowledge of medical terminology, research policies and guidelines, infectious-substance packing and shipping guidelines, database building and analysis, and data management using platforms 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 regarding 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 potential subjects; develop recruitment and retention strategies; screen and enroll study subjects.
Schedule study visits, administer questionnaires, collect medical histories, and perform study procedures.
Maintain relationships with subjects, support communication and retention, respond to participant needs, schedule follow-up appointments, and coordinate with providers regarding study outcomes and continuity of care.
Obtain informed consent, review study information with subjects, and advocate for participant safety throughout protocol procedures.
Oversee subject reimbursement and help resolve discrepancies and issues.
Coordinate with staff to ensure procedures are completed, specimens are stored properly, required visit data are collected, and samples are labeled and shipped correctly.
Coordinate scheduling and communication with other studies, technicians, affiliated groups, and collaborating staff.
Review medical charts and electronic records to extract information and data for studies.
Assess and recommend improvements to patient coordination, data collection and management, protocol adherence, and study collaboration.
Collect and enter data from visits, procedures, laboratory tests, and other study participation into databases in a timely manner.
Manage and improve protocol database structures, create databases as needed, and maintain comprehensive datasets and data collection forms.
Perform database queries and analyses; work with the Supervisor to maintain accurate study databases and analyze available data.
Attend and actively participate in team meetings.
Train staff and team members on protocols, procedures, data collection and entry, database procedures, medical chart review, and related processes.
Oversee data integrity, assess recruitment and data-management policies and procedures, maintain procedure manuals, and implement periodic quality-control procedures.
Suggest administrative infrastructure changes to accommodate study complexity; modify data collection instruments; help schedule staff and maintain subject tracking systems.
Arrange the exchange and transport of specimens with collaborating investigators and staff; oversee incoming sample data and ensure samples are used appropriately for analyses and publications; protect sample integrity and security.
Enter existing and new protocols in the CHR online system and communicate with CHR Analysts about protocol maintenance.
Design and improve case report 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; track timely submissions and serve as a liaison between CHR and study investigators.
Conduct quality-assurance checks on protocols and CHR applications, evaluate protocols on an ongoing basis, and implement improvements.
Ensure studies comply with the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Initiate and follow up on CHR submissions and modifications, track approval status, and obtain UCSF approval before study initiation.
Maintain regulatory documents, monitor data-submission timelines, and document adverse events for submission to appropriate departments.
Protect patient confidentiality when communicating with agencies, healthcare providers, studies, and outside departments.
Participate in and cooperate with internal and external audits and protocol reviews, and prepare required documentation.
Perform other duties as assigned.