Clinical Research Coordinator

About the role

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 research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Responsibilities

• Study Coordination and Data Collection: Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects. Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history, and perform study procedures. Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary. Discuss study outcomes with providers to ensure continuity of care. Obtain informed consent; 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, specimens are properly stored, and required data are collected at visits; and ensure correct shipping and labeling measures. Coordinate, communicate, and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups. Conduct reviews of medical charts and electronic records 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 management and reporting of results: Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation 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. Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI. Maintain data collection forms for effective data collection, entry, and analysis. Perform queries and analysis in databases. Work with the 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 on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, 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. 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. Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies. Modify data collection instruments. Help schedule staff time and coordinate staff schedules. Maintain subject tracking systems. Arrange the exchange of and transport of specimens with collaborating Investigators and staff. Ensure integrity and security of samples.

• Quality control procedures: Ensure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. Initiate and follow up on CHR submissions and modifications; track approval status. Interface with departments to obtain UCSF approval prior to study initiation. Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments. 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.

Qualifications

• HS graduation and experience in clinical research coordination, clinical research operations, or related research environment involving human subjects.
• 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 multi-task 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.
• Knowledge of clinical research regulations and guidelines, including: Good Clinical Practice (GCP), Human Subjects Protection regulations, Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Board (IRB) processes and compliance requirements.
• Experience coordinating clinical research studies, including participant recruitment, informed consent procedures, study visit coordination, and protocol implementation.
• Experience collecting, documenting, and managing research data, including completion and maintenance of case report forms (CRFs) and maintaining accurate study records.
• Ability to accurately execute Clinical Research protocols in a timely manner. Ability to coordinate multiple concurrent clinical research studies and manage competing priorities while maintaining protocol compliance.
• Experience working directly with research participants or patients, including scheduling visits, coordinating procedures, and maintaining professional communication.
• Experience collecting, processing, and coordinating the shipment of biological specimens in accordance with study protocols and safety regulations.
• Strong organizational, analytical, and problem-solving skills, with demonstrated ability to manage detailed documentation and maintain data integrity.
• Effective interpersonal and communication skills, with the ability to collaborate with investigators, clinicians, research staff, and external partners.
• Proficiency with Microsoft Office software (Word, Excel, etc.).
• Excellent problem-solving skills. Interest and ability to work with participants in a Clinical Research setting.
• Proficiency with standard computer applications and research documentation tools, including electronic medical records and database systems.