Clinical Research Coordinator

Under the supervision of the Clinical Research Supervisor, Clinical Research Coordinators (CRC) support the clinical trial management of investigator-sponsored, pharmaceutical-sponsored, and/or other types of consortium trials programs as assigned/needed. Responsibilities include communicating with the Clinical Research Supervisor to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval, and report study progress to the appropriate PI. The CRC will support 4-5 research studies that are studies in patients with cancer and benign urologic diseases. This may include active and follow-up studies, depending on the complexity of the patients and procedures. Independently, the CRC maintains protocol files, data collection and subject source records, develops project management documents and electronic data forms for each assigned study. The CRC supports the investigator in research study project management to assure compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies and IRB protocols. The CRC also supports the research team with additional duties as assigned (e.g., obtaining archived biospecimens or data for ongoing studies).

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YES

Study Coordination and Data Collection

• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Schedule subjects for study visits at clinic at Mission Bay; collect medical history and perform study procedures at clinic or via mail to patients home and self-addressed courier.
• 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.

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
• 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

Study Implementation

Protocol Submissions and Adherence (as needed)

• 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.
• Work with other centers to facilitate IRB approval
• 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.
• 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

Protocol Management: Protocol management is an ongoing activity throughout the period of the trial. 

• Studies open to enrollment: Assist physicians in screening and checking eligibility for potential candidates for the clinical trials using multiple hard copy and electronic databases including REDCap, APEX, clinical notes, and medical records; Initiates first contact with potential study candidate to introduce possible, appropriate clinical trial; Consents study participants; Registers participants to appropriate registration system; Maintains patient tracking forms, reporting and recording adverse events, and collection of correlative specimens as required. The CRC must coordinate activities with multiple departments, i.e., Infusion center, lab or radiology, as well as coordinate protocol recruitment and correlative specimen collection with non-UCSF sites, and schedule tests. Problems in either of these areas will lead to failed trials or put study subjects in jeopardy. 

• Studies with Follow-up: The CRC must create follow-up tracking forms, maintain protocol reports, record data points in electronic databases, assist the Principal Investigator with publication, data analysis, and coordinate drug accountability with the sponsoring company. There can be several protocols requiring follow-up protocol management. 

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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.

Specimen Management/ Maintenance

• 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.
• 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

Data Management: Data and biospecimen collection and management for clinical trials and population studies in the Department of Urology involving prostate, renal, and bladder cancer and benign conditions for departmentally managed clinical trials and study registries. Abstract, manage, and maintain records on multiple databases which track clinical outcomes of patients being treated for urologic health. Abstracts data from medical records and enters medical information/data onto protocol specific case report forms (CRFs), study flow sheets, multiple electronic databases and other required study forms for specific protocols.

Staff training

5

• 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.
• Possess strong skills for multitasking, meeting competing deadlines, prioritizing and supporting PIs for multiple departments.
• Outstanding communication skills
• Ability to learn new tasks quickly and apply good judgement in unexpected situation