Clinical Research Coordinator

Responsibilities

• 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.
• Prepare laboratory setups and paperwork for specimen collection and tracking.
• Coverage for other CRCs, under Supervision, in implementing HIV- and PrEP-related clinical research protocols.
• 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.
  • The most commonly used database in our group is Redcap.
  • 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.
  • Work with the PI/PD 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.
  • Document work flow and create/update protocols for training and grant-reporting purposes.
  • 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.
• 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.
• Study Implementation
  • Modify data collection instruments.
  • Schedule staff time and coordinate staff schedules.
  • Maintain subject tracking systems.
  • Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
  • Other administrative duties as necessary e.g., scheduling meetings, taking meeting minutes, filing, purchasing.
  • Setup and maintain petty cash fund of up to $2000 as well as check requests for research subject stipends and manage gift card reimbursements.
  • Follow proper subject reimbursement procedures.
  • Ensure appropriate and accurate charges are applied to the correct study fund.
  • Work directly with accounting department to set up new systems for funding needs as they arise, including developing purchase orders for necessary goods/services.
  • Aid in the management of a complex network of vendors used for study related costs for lab/office supplies, subject transportation, courier and clinical lab services etc.
• Specimen Management/ Maintenance
  • Arrange or perform the exchange of and transport of specimens.
  • Identify and request needed laboratory supplies and place orders in the procurement system.
  • Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
  • Ensure integrity and security of samples.
• 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.
  • Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.