Limited Appointment Senior Clinical Research Coordinator

About the role

This is a limited appointment ending June 30, 2027. The Senior Clinical Research Coordinator independently coordinates and is accountable for the overall administration of several clinical studies, requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel. This role may serve several divisions within the department including but not limited to: hematology, medical genetics and allergy/immunology/BMT.

Responsibilities

• Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-trial agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance.

• 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. Obtain 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.

• Cook up and communicate 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.

• Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects’ options, and ensure that documentation and storage of study files meets legal requirements.

• Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all CHR documents are up to date. Oversee preparation of new CHR applications; arrange paperwork for renewal of existing protocols; respond to CHR requests for revisions; and coordinate protocol changes with study sponsors.

• Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.

• 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.

• Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables. Design and perform ad-hoc performance analysis of the projects and the project staff. Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects. Perform business process review, operational reviews and design and implement workflow and controls. Develop project-related presentation material for study. Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.).

• Aid in recruiting and training clinical research coordinators in collaboration with leadership. Provide guidance to clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures. Train others in federal and local research laws and guidelines. Help manage personnel needs as needed. Attend and actively participate in regular team meetings.

• Oversee budgets, invoices, and reimbursements. Ensure billing is appropriate and accurate to avoid improper billing of Medicare, private insurance, or patients. Review budget reports on a monthly basis. Along with the PI, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds. Responsible for ensuring that the use of research funding is in compliance with funding agency protocols. Assist PI in grant development, focusing on budget development.

• 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.

• Protect the University from non-compliance and potential litigation by ensuring contract compliance, meeting local and federal laws, and ensuring compliance with hiring and supervision laws; implement safeguards and proper compliance with federal and local regulations to ensure audit prevention and success. Act as regulatory authority and advisor by training and educating employees and advising leadership and PI’s. Manage audits. Help institute and maintain a Quality Improvement Process.

Qualifications

• Bachelor’s degree in related area 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 companies; 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.
• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills.
• Ability to analyze complex and non-routine issues requiring innovative solutions.
• Ability to operate effectively in a changing organizational and technological environment.
• Ability to assess and respond to audit risk; ability to develop and implement quality improvement processes.