Clinical Research Coordinator

About the role

The Clinical Research Coordinator (CRC) will join a mission-driven research team dedicated to improving care for people with opioid use disorder (OUD) through innovative, patient-centered clinical research. This position provides an exciting opportunity to help launch and coordinate a pragmatic randomized controlled trial (RCT) comparing two approaches to buprenorphine initiation among people using fentanyl. The study is based at the San Francisco Outpatient Buprenorphine Induction Clinic (OBIC) and is a collaboration between UCSF, the San Francisco Department of Public Health, and community partners.

Responsibilities

• Meet with study participants in-person to conduct study visits, including study surveys related to participant demographics and substance use histories, gathering and interpreting urine drug screen testing, communicating with participants to schedule follow up study visits, providing payment to participants
• Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
• Assure inclusion/exclusion criteria are met
• Randomize participants according to study protocol
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Complete Adverse Event Reporting during study visits and submit reporting to IRB
• Schedule and prepare reporting to Data Safety Monitoring Board
• Be prepared to triage participants in emotional distress.
• Modify data collection instruments
• Aid in conducting literature review
• Implement needs assessments and recommendations for enhancements on participant coordination, data collection, data management, protocol adherence and study collaboration.
• Analyze the data as they become available; provide manuscript feedback

Data management and reporting of results

• Collect data during subject visits into databases in a timely manner.
• Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Perform queries and analysis in databases.
• Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.

Staff training

• Help train staff and others conducting study visits, including data collection, informed consent, codebook development and coding, as well as changes in procedures, study protocols, data collection/entry, database procedures, and other procedures.
• Attend and actively participate in regular team meetings.
• Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Supervise Assistant CRC to ensure compliance with protocol as well as HIPAA requirements.
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Interface with departments to obtain study site approval prior to study initiation.
• Maintain regulatory documents and monitor timelines for data submission.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Identify subjects, help develop recruitment strategies, and screen and enroll study subjects.
• Cookordinate, communicate, and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
• Report on progress of all studies to appropriate affiliates, including funding organizations, stakeholders, IRB, and other associated agencies.

Quality control procedures and regulatory responsibilities

• Aid in conducting literature review
• Implement needs assessments and recommendations for enhancements on participant coordination, data collection, data management, protocol adherence and study collaboration.
• Analyze the data as they become available; provide manuscript feedback

Study Coordination

• Coordinate, communicate, and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
• Report on progress of all studies to appropriate affiliates, including funding organizations, stakeholders, IRB, and other associated agencies.

Protocol Submissions and Adherence

• Assist with renewing, modifying, and submitting IRB applications and protocols in a timely manner
• Assist with grant applications, including gathering supporting materials and budgeting.
• Design and enhance data collection forms as needed.
• Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.