Clinical Research Coordinator

University of California, San Francisco•San Francisco, CA

11d

About The Position

The Clinical Research Coordinator (CRC) works in the Stress and Health Research Program at the San Francisco VA Medical Center (SFVA), under the direction of Dr. Thomas Neylan of UCSF. At the fully operational journey level, the CRC independently or with general direction executes, manages, and coordinates research protocols as directed by the Principal Investigator. The role coordinates data collection and operations for several concurrent clinical research studies in accordance with study protocols and UCSF, SFVA, and regulatory agency policies. Studies may focus on PTSD and sleep disruption in veterans and civilians. The CRC acts as an intermediary between UCSF and SFVA services and departments, oversees recruitment and enrollment, and coordinates recruitment and data collection for multi-site studies within the VA system. Duties include participant screening and visit coordination; data and specimen management; use and preparation of sleep equipment; study result reporting; database and dataset maintenance; staff scheduling and training support; regulatory compliance; preparation for audits and reports; data-integrity and quality-control oversight; securing SFVA departmental approvals; maintaining regulatory documents; and reporting study progress to investigators. The CRC also prepares at-home sleep measurement devices, collects basic vital signs and medical history, and performs other assigned duties.

Requirements

High school graduation and sufficient experience and demonstrated skills to perform the assigned duties and responsibilities, and/or equivalent experience or training.
Attention to detail, strong interpersonal skills, and excellent verbal and written communication skills.
Ability to coordinate effectively with study subjects, team members, other departments, and outside institutions.
Ability to multitask in a fast-paced environment and work with a diverse subject population.
Ability to work independently, complete projects promptly, and prioritize multiple projects to meet deadlines.
Experience coordinating remote studies, clinical trials, and data collection.
Experience coordinating multi-site VA studies.
Experience administering at-home sleep-monitoring devices.
Knowledge of SFVA policies for reimbursement, research, confidentiality, and HIPAA; patient-safety and confidentiality procedures; medical terminology; research policies and guidelines; SFVA biosafety regulations; SFVA shipping and mailing; reservation and use of shared SFVA research space; and data management.
Experience working with ApneaLink assessments for sleep apnea.
Experience applying Good Clinical Practice Guidelines, HIPAA, protections for human research subjects, and UCSF IRB and SFVA HRPP regulations for recruitment and consent.

Nice To Haves

At least 3 years of experience working with veteran patients at a VA medical facility.
At least 3 years of experience working with veterans and/or civilians with a history of psychological trauma or PTSD.
Level 1 MRI safety training for SFVA researchers.
A BA or BS degree in a related field, with sufficient experience and demonstrated skills to perform the assigned duties and responsibilities.

Responsibilities

Identify potential participants, develop recruitment and retention strategies, screen and enroll study subjects, and conduct recruitment using VA resources and referrals.
Coordinate with other VA study sites to support enrollment goals and ensure protocol-compliant data collection and testing.
Schedule study visits, administer questionnaires, train participants on sleep equipment, collect medical history, and conduct other study procedures.
Maintain communication and rapport with participants, support retention, respond to participant needs, and arrange follow-up appointments.
Obtain informed consent and VA HIPAA Authorization, explain study information, and advocate for participant safety throughout protocol procedures.
Oversee subject reimbursement and help resolve discrepancies or issues.
Coordinate staff and study procedures to ensure required data are collected and shipping and labeling requirements are followed.
Coordinate with VA departments, clinical staff, technicians, affiliated groups, and other recruitment sources to support scheduling and referrals.
Escort participants to VA laboratory, MRI, and other appointments and provide additional safety coverage as required.
Review VA CPRS medical charts and extract medical information and other data for studies.
Recommend improvements to patient coordination, data collection, data management, protocol adherence, and study collaboration.
Collect and enter participant visit, procedure, and participation data into databases in a timely manner.
Work with the Database Manager to create and maintain protocol database structures and improve databases for analysis and management.
Maintain data collection forms and complete, accurate study database records; coordinate multi-site data entry and oversee data-quality control.
Troubleshoot recognizable sleep apnea recording defects or malfunctions and manage maintenance of at-home sleep-testing supplies.
Assist with training staff on SFVA recruitment methods, study coordination, and access to SFVA resources.
Attend and actively participate in regular team meetings.
Assess the adequacy of procedures for recruitment, data collection, and data management; maintain a procedure manual and help ensure consistency in data collection and entry.
Implement and maintain periodic quality-control procedures and oversee study data integrity.
Suggest modifications to administrative infrastructure to accommodate increasingly complex studies; modify data-collection instruments; and help coordinate staff schedules and space allocation.
Maintain subject-tracking systems.
Ensure studies follow the Code of Federal Regulations, Good Clinical Practice, and SFVA and UCSF regulations.
Obtain SFVA departmental approval before study initiation, maintain regulatory documents, monitor data-submission timelines, and document and report adverse events to appropriate departments.
Prepare materials for annual SFVA consent audits and other SFVA HRPP audits and queries.
Protect patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.