Clinical Research Coordinator

UCSF•San Francisco, CA

12d•$40 - $47•Onsite

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 UCSF Director Dr. Thomas Neylan. 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 (PI), coordinating data collection and operations for multiple concurrent clinical research studies in accordance with study protocols and UCSF, SFVA, and regulatory agency policies. The role supports studies focused on PTSD and sleep disruption in veterans and civilians. The CRC serves as an intermediary between UCSF and SFVA services and departments; oversees recruitment, enrollment, screening, participant visits, and data and specimen management; coordinates data collection for multi-site VA studies; and uses sleep equipment for data collection. The CRC also manages study databases, datasets, reports, quality control, regulatory documentation, audits, and staff schedules and training. Duties include obtaining approvals before study initiation, reporting progress to investigators, attending team meetings, preparing at-home sleep-measuring devices, collecting basic vital signs and medical history, and performing 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 and strong interpersonal skills.
Excellent verbal and written communication skills for coordinating with subjects, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment with a diverse subject population.
Ability to work independently, complete projects on time, 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 regarding reimbursement, research, confidentiality, and HIPAA; patient safety and confidentiality procedures; medical terminology; research policies and guidelines; SFVA biosafety regulations; shipping and mailing from SFVA; 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.
BA or BS degree in a related field, together with sufficient experience and demonstrated skills to perform the assigned duties and responsibilities.

Responsibilities

Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
Coordinate with other VA sites to meet enrollment goals and ensure data collection and testing follow study protocols.
Conduct recruitment through VA resources, including CPRS/VINCI lists, VA Public Affairs, and VA clinic referrals.
Work with SFVA clinical staff and other recruitment sources to receive and track patient referrals.
Schedule study visits; administer questionnaires; train subjects on sleep equipment; collect medical history; and conduct other study procedures.
Maintain relationships with subjects, communicate effectively, respond to diverse needs, and schedule follow-up appointments to support retention.
Obtain informed consent and VA HIPAA Authorization, review information with subjects, and advocate for patient safety throughout protocol procedures.
Oversee subject reimbursement and resolve related discrepancies or issues.
Coordinate with staff to ensure procedures are completed, required data are collected, and shipping and labeling are correct.
Coordinate with VA departments, technicians, and affiliated groups to support scheduling efficiency.
Escort subjects to VA lab, MRI, and other appointments, and provide additional safety coverage as required.
Review VA CPRS medical charts and extract medical information and other study data.
Assess and recommend enhancements to patient coordination, data collection and management, protocol adherence, and study collaboration.
Collect visit data and enter data from visits, procedures, and other participation 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 databases.
Coordinate data entry for multi-site VA studies and oversee data-collection and entry quality control.
Ensure sleep apnea recording integrity by troubleshooting recognizable defects or malfunctions.
Manage maintenance of at-home sleep-testing supplies.
Assist with staff training on SFVA recruitment methods, study coordination, and accessing SFVA resources.
Attend and actively participate in regular team meetings.
Oversee data integrity and assess the adequacy of policies and procedures for recruitment, data collection, and data management.
Maintain a procedure manual and help develop plans for consistent data collection and entry.
Implement and maintain periodic quality-control procedures.
Suggest administrative infrastructure modifications to accommodate increasing study complexity.
Modify data-collection instruments.
Help schedule staff time and coordinate staff schedules and space allocation for intermittent staff.
Maintain subject-tracking systems.
Ensure studies comply with the Code of Federal Regulations, Good Clinical Practice, and SFVA and UCSF regulations.
Interface with departments to obtain SFVA approval before study initiation.
Maintain regulatory documents, monitor data-submission timelines, document adverse events, and submit them to appropriate departments.
Prepare materials for annual SFVA consent audits and other SFVA HRPP audits and queries.
Use sound judgment to protect patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
Prepare data for annual audits and reports, report study progress to investigators, and perform other duties as assigned.