Clinical Research Coordinator

University of California, San Francisco•San Francisco, CA

13d

About The Position

The Clinical Research Coordinator (CRC) performs independently or with general direction at the fully operational journey level to execute, manage, and coordinate research protocols as directed by the Clinical Research Supervisor and/or Principal Investigator (PI). The role may coordinate data collection and operations for several concurrent clinical research studies under research protocols and UCSF and regulatory agency policies. The CRC supports neurologists and other members of the Movement Disorders and Neuromodulation division in coordinating clinical research studies and clinical care, including drug treatments and observational studies for patients with Parkinson’s disease and other movement disorders. The position involves frequent interaction with patients; coordinating and attending complex clinic and study visits; collecting research data and managing databases; collecting, processing, and shipping biological specimens; managing case report forms and supplies; and maintaining regulatory documents. The CRC may support single or multiple studies depending on their size and complexity, coordinate tasks across services and departments, manage and report study results, create and maintain datasets and reports, coordinate staff schedules, assist with training and staff oversight, and manage study protocols and submissions through UCSF’s Committee on Human Research (CHR) system. The CRC also supports protocol development and institutional review board approval, regulatory compliance, data integrity, quality control, study initiation approvals, progress reporting, and audits or reviews.

Requirements

High school graduation and experience in clinical research coordination, clinical research operations, or a related research environment involving human subjects.
Attention to detail; strong interpersonal skills; and excellent 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 subject population.
Ability to work independently, complete projects on time, and prioritize competing projects to meet deadlines.
Knowledge of clinical research regulations and guidelines, including Good Clinical Practice (GCP), human-subject protection regulations, HIPAA, and IRB processes and compliance requirements.
Experience coordinating clinical research studies, including participant recruitment, informed consent, study-visit coordination, and protocol implementation.
Experience collecting, documenting, and managing research data, including completing and maintaining case report forms and accurate study records.
Ability to accurately execute clinical research protocols in a timely manner.
Ability to coordinate multiple concurrent clinical research studies and manage competing priorities while maintaining protocol compliance.
Experience working directly with research participants or patients, including scheduling visits, coordinating procedures, and maintaining professional communication.
Experience collecting, processing, and coordinating shipment of biological specimens in accordance with study protocols and safety regulations.
Strong organizational, analytical, and problem-solving skills, including the ability to manage detailed documentation and maintain data integrity.
Ability to collaborate effectively with investigators, clinicians, research staff, and external partners.
Proficiency with Microsoft Office software, including Word and Excel.
Interest and ability to work with participants in a clinical research setting.
Ability to work onsite depending on project needs.
Proficiency with standard computer applications and research documentation tools, including electronic medical records and database systems.

Responsibilities

Identify potential participants; develop recruitment and retention strategies; and screen and enroll study subjects.
Schedule study visits; administer questionnaires; collect medical history; and perform study procedures.
Maintain communication and rapport with subjects, support retention, address participant needs, arrange follow-up, and serve as an intermediary for participants.
Obtain informed consent, review study information with subjects, and advocate for patient safety during protocol procedures.
Oversee subject reimbursement and help resolve discrepancies or related issues.
Coordinate staff and study procedures to ensure specimens are properly stored and required data are collected, 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 for studies.
Identify needs and recommend improvements in patient coordination, data collection and management, protocol adherence, and study collaboration.
Collect and enter data from visits, procedures, laboratory tests, and other participation into databases in a timely manner.
Manage and improve protocol databases, create databases as needed, maintain comprehensive datasets and data collection forms, and perform database queries and analyses.
Work with the supervisor to maintain accurate and complete study data and analyze data as it becomes available.
Help train staff on protocols, procedures, data collection and entry, database processes, chart review, and related procedures.
Participate in team meetings; oversee data integrity; assess policies and procedures; maintain procedure manuals; and support consistent data collection and entry.
Implement periodic quality-control procedures, suggest administrative infrastructure changes, modify data collection instruments, and help coordinate staff schedules.
Maintain subject-tracking systems and coordinate specimen exchange and transport with collaborating investigators and staff; ensure sample integrity and security and appropriate use of sample-derived data.
Enter and maintain study protocols in the CHR online system; renew, modify, and submit CHR applications and protocols; track approvals and coordinate with CHR analysts and investigators.
Design and improve case report forms and data collection forms, provide manuscript feedback, and maintain systems for protocol adherence and data quality.
Participate in protocol review and writing to support institutional review board approval and University compliance; evaluate protocols and applications and implement improvements as needed.
Ensure studies follow the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Obtain UCSF approvals before study initiation, maintain regulatory documents, monitor data-submission timelines, and document and submit adverse events 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 or protocol reviews and prepare necessary documentation.
Perform other duties as assigned.