Clinical Research Coordinator
UC San Francisco (UCSF) · San Francisco, California, United States
The Clinical Research Coordinator (CRC) will work in the Stress and Health Research Program at the San Francisco VA Medical Center (SFVA), under Director Dr. Thomas Neylan of UCSF. They will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI); coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF, SFVA, and regulating agency policies.
The CRC's duties may include, but will not be limited to the coordination of activities in research studies
focused on PTSD and sleep disruption in veterans and civilians. They will act as intermediary between services and departments at UCSF and the SFVA while overseeing study recruitment and enrollment; coordinate recruitment and data collection for multi-site studies in the VA system; manage participant screening; oversee data and specimen management; will utilize sleep equipment for data collection; manage and report on study results; clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules and assist with training of other lab personnel; help assure compliance with all relevant regulatory agencies; prepare data for annual audits and reports; oversee study data integrity; implement and maintain periodic quality control procedures; interface with SFVA departments to obtain approval prior to study initiation; maintain all regulatory documents; report study progress to investigators and attend team meetings; prepare at-home sleep measuring devices; collect basic vital signs and medical history; and perform other duties as assigned.
Study Coordination and Patient Management
• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• As CRC with the primary VA study site, will coordinate with other VA sites to ensure enrollment goals are met and all data collection and testing is conducted according to study protocol.
• Conduct recruitment using VA resources such as CPRS/VINCI lists, VA Public Affairs, VA Clinic referrals.
• Work closely with SFVA clinical staff and all other recruitment sources to receive and track patient referrals.
• Schedule subjects for study visits; meet with them to administer questionnaires, train them on sleep equipment, collect medical history, and perform other study procedures.
• Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments.
• Obtain informed consent and VA HIPAA Authorization; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Work with staff to ensure procedures are completed; required data collected at visits; and ensure correct shipping and labeling measures.
• Coordinate, communicate and network with other VA departments and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
• Escort subjects to VA lab, VA MRI and other appointments; provide additional safety coverage as required by those departments.
• Conduct reviews of VA CPRS medical charts to extract medical information and other data for use in studies.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
Data and Equipment Management
• Collect data during subject visits; enter data from visits, procedures, and other subject-related participation into databases in a timely manner.
• Work with Database Manager to create and maintain database structure for each protocol; update databases to improve data analysis and management.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Maintain complete and accurate data in the study database.
• Coordinate data entry for multi-site VA studies; overseeing quality control of data collection and entry.
• Ensure sleep apnea recording integrity by troubleshooting common recognizable defects/malfunctions.
• Manage the maintenance of the at-home sleep testing supplies.
Staff training
• Assist with the training of staff on SFVA recruitment methods, study coordination, and accessing SFVA resources for study teams.
• Attend and actively participate in regular team meetings.
Quality control procedures
• Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Implement and maintain periodic quality control procedures.
Study Implementation
• Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
• Modify data collection instruments.
• Help schedule staff time and coordinate staff schedules and space allocation for intermittent staff.
• Maintain subject tracking systems.
Regulatory responsibilities
• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and SFVA and UCSF regulations.
• Interface with departments to obtain SFVA approval prior to study initiation.
• Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
• Prepare materials for annual SFVA consent audits and other SFVA HRPP audits and queries.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
Required Qualifications
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multitask in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by 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 dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of 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 the following regulations and guidelines:
o Good Clinical Practice Guidelines
o Health Information and Accountability Act (HIPAA)
o The Protection of Human Research Subjects
o UCSF IRB and SFVA HRPP regulations for recruitment and consent of research subjects
Preferred Qualifications
• 3+ years of experience working with veteran patients at a VA medical facility.
• 3years of experience working with veterans and/or civilians with history of psychological trauma or PTSD. Level 1 MRI safety training f