Clinical Research Coordinator

Job Description 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). The Coordinator may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. Incumbent’s duties may include, but will not be limited to, supporting the management and coordinating the tasks of single or multiple clinical research studies, acting as an intermediary between services and departments while overseeing data and specimen management, managing and reporting on study results, creating, cleaning, updating, and managing databases and comprehensive datasets and reports, coordinating staff work schedules, assisting with training of Assistant CRCs, and assisting the Clinical Research Supervisor and/or PI with oversight of other research staff. The Coordinator will also manage Investigator’s protocols in the Committee on Human Research online system, handle renewals and modifications of protocol applications and implement new studies, participate in the review and writing of protocols to ensure institutional review board approval within University compliance, help assure compliance with all relevant regulatory agencies, oversee study data integrity, implement and maintain periodic quality control procedures, interface with departments to obtain UCSF approval prior to study initiation, maintain all regulatory documents, report study progress to investigators, participate in any internal and external audits or reviews of study protocols, and perform other duties as assigned. 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 properly stored, and required data 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 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. Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications. Ensure integrity and security of samples. Quality Control Procedures Implement and maintain periodic quality control procedures. Study Implementation No duties specified for study implementation. Specimen Management / Maintenance Manage specimen collection, storage, and maintenance processes. Protocol Submissions and Adherence Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts. Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality. Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance. Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators. 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. Regulatory Responsibilities Assure 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. Qualifications 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 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. Preferred Qualifications Previous experience with neurodevelopmental assessment of infants and children under 3 years old. Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation. #J-18808-Ljbffr