Clinical Research Coordinator - Cancer Center (Berkeley/Burlingame)

% 

of time (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

40%

YES

Study Coordination, Implementation, and Data Collection

• Work with the PI, CRM, Operations Manager, and research team to identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects; prepare protocols for initiation, which includes working knowledge of federal, state, and local research regulations and guidelines, and cancer center clinical practice methods
• Schedule subjects for and facilitate study visits; meet with patients 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.
• Review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
• Oversee subject billing and reimbursements; work to resolve discrepancies and issues in a timely manner.
• Work with PI and study and clinic staff to ensure study procedures are completed. Coordinate, communicate and network with other studies staff and technicians to ensure scheduling efficiency; communicate with any affiliated groups to ensure patient safety.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Under the supervision of the PI, the study investigators, Operations Manager, and the CRM, educate and provide to the clinical staff specific protocol information on clinical care to treat study patients safely; relay information on the study drug and help provide study information to the clinical staff and to the patients.
• Suggest modifications to the study process to improve efficiencies.

30

YES

Data management,  reporting of results, and quality control

• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject- related participation into databases in a timely manner.
• Collect, report and manage data for patients on follow-up 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 study source documentation, tracking of blood/tissue samples, and other protocol activities to ensure compliance.
• Create and maintain comprehensive data sets as requested by the Operations Magnagner, CRM and/ or PI.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Respond to queries and analysis in databases within a timely mannerdesignated timeframes.
• Work with Supervisor to maintain complete and accurate data in the study database and other internal databases such as OnCore; analyze the data as they become available.
• Utilize various data collection and data reporting instruments, including databases of sponsored studies, (OnCore, iRis, Apex EMR).
• Maintain subject tracking systems in all databases as applicable.
• 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; ensure consistency in data collection and data entry.
• Implement and maintain periodic quality control procedures

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.
• Ensure that specimens are properly stored, and shipped according to all laboratory policies and safety measures.
• 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 correctly entered into respective databases, and reviewed by the Investigator
• Ensure integrity and security of samples.

YES

YES

Study Implementation

YES

Specimen Management/ Maintenance

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.

15

YES

Regulatory responsibilities

• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Initiate and follow-up on iMEDris IRB submissions for single-patient exceptions, adverse event reporting, and protocol violations.
• 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.

10

Other duties

• Attend and actively participate in regular team meetings as well as professional development opportunities
• Must be a team player and participate in staff- wide assignments outside of protocol management, including: filing, cleaning and maintaining study supplies, maintaining common work spaces (office space and laboratory space); development of policies and procedures, and other duties as assigned by the CRM, Principal Investigator, and Operations Manager.

100%