Job Description

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. The CRC will be part of a close-knit group committed to advancing health equity and expanding access to effective addiction treatment.

Working under the direction of the Principal Investigator (PI) and research team, the Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate study protocols. Responsibilities will include coordinating recruitment and enrollment, obtaining informed consent, managing study visits, collecting survey and clinical data, maintaining regulatory compliance, and ensuring smooth day-to-day study operations in accordance with UCSF and federal guidelines.

Responsibilities

of time (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

50

YES
Data Collection and study implementation

• 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

20

YES
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.

10

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.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.
• Identify subjects, help develop recruitment strategies, and screen and enroll study subjects.
• 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.

5

YES

Quality control procedures and regulatory responsibilities

10

YES
Study Coordination

5

YES

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.

100%
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

Qualifications

Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Prior experience with clinical research: recruiting, interviewing, eliciting informed consent, and explaining study requirements to participants in clinical research studies.
• Demonstrated communication in and English-written, verbal and interpersonal skills.
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Proficiency with iPhone, Zoom, Microsoft Word, PowerPoint, and Windows.
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with other scientists and community organizations.
• Demonstrated strong administrative and organizational skills.
• Prior experience in a healthcare and/or clinical research environment sufficient to understand medical records, confidentiality, and common healthcare information procedures.

Preferred Qualifications:

• Prior experience in conducting and facilitating randomized clinical trials
• Demonstrated communication in English and Spanish-written, verbal and interpersonal skills.
• Familiarity with working with populations affected by substance use or structural vulnerabilities.
• Knowledge of REDCap, Qualtrics, or similar research data management systems.
• Experience conducting participant interviews or survey administration.
• Excellent organizational, communication, and interpersonal skills.
• Ability to work both independently and collaboratively within a diverse, multidisciplinary team.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy.

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html