Clinical Research Supervisor

Responsibilities

• Distributes work. Monitors the progress of work of assigned staff. Researches and resolves issues and discrepancies. Manages subordinates' quality and quantity of work to ensure unit meets its objectives. Reports performance evaluation to management.
• Supervises the timeliness and quality of data collection, submission and completion. This includes training new study coordinators in collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events and protocol adherence to federal regulations. Train, supervise, CRCs in coordinating clinical studies emphasizing the priority of patient safety and timely data reporting for CTEP, industry sponsored, and Investigator-sponsored studies while maintaining scientific integrity of the study.
• Train, supervise, CRCs for reviewing medical history, performing study procedures, collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events, using medical charts and electronic records to extract medical information, and utilizing various data collection instruments including databases of sponsored studies, OnCore, iMEDris, and Apex EMR.
• Follows internal policies and processes. Supervises assigned staff to ensure compliance. Trains employees on research regulatory processes, database entry, and working with participant families. Implements and maintains defined research study processes. Acts as resource to CRC, to ensure accuracy in eligibility verification for each patient placed on a clinical trial to ensure human subject protection regulations comply and quality recruitment.
• Serves as a liaison between staff and program leaders. Reports work effort to the department. Cultivates communication and teamwork between cross-functional teams working on research.
• Initiates a clinical trial study. Oversees and reviews study and helps create systems and forms to ensure research billing, packets for recruitment and calendars are developed. Reviews accrual and eligibility for each patient placed on a clinical trial to ensure human subject protection regulations are in compliance and quality recruitment.
• Multi-tasks and prioritizes to smoothly coordinate studies and ensure patient safety. Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. Initiate and follow-up on iRIS 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.
• Uses 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.
• Facilitate start-up and study coordination at external sites for multi-site investigator initiated studies.
• Makes sure data is sufficient and updated, including all regulatory documentation. Uses computer applications to generate reports and quality assurance of required data entry. Attends all meetings with auditors. Assists staff assigned with monitoring site compliance.
• Trains, supervises, and guide CRCs to prepare for monitoring and audit visits, including ensuring all study documents are complete, organized, and current, all data is submitted and queries answered, and all action items from prior visits are completed. Reviews and analyzes monitoring and audit reports for industry-sponsored, investigator initiated, and cooperative group studies to ensure action items are completed.
• Identifies and addresses key areas for improvement related to training and performance management. In conjunction with the Clinical Research Manager, identifies areas where process improvements are needed.
• Tracks patient charges and alerts the department on billable triggers to collect money. Understands budget preparation for clinical trials; interprets and trains the study coordinators on how to proceed in proper data research billing. Coordinates with billing to resolve disputed charges.
• Trains, supervises, and guide CRCs to consult and interpret coverage analyses, communicate billing practices to patients, and properly and in a timely manner route billing of study procedures via electronic billing systems. May offload more complicated billing issues from CRCs. May collaborate with partners in ancillary departments, including clinic team, billing offices, and information technology team to troubleshoot individual instances of improper billing; communicates with Clinical Research Manager to facilitate recognition of trends and improve processes.
• May be responsible for working with Clinical Research Manager and Protocol Project Manager in managing the funds for the study, including assisting with tracking and reporting invoiceables to the post-award team to ensure timely patient reimbursement.
• Provides excellent judgment and initiative to ensure procedures are properly billed to optimize patient care and use of limited resources, may assist Clinical Research Manager in creating systems to ensure these operations are properly implemented.
• Recommends salary actions, promotions, and terminations. Recommends personnel-related actions. Participates in the recruitment and orientation of new employees. Evaluates assigned staff performance and reports to management. Provides guidance and excellent judgement. Seen as a role model by assigned staff.

Qualifications

• Bachelor's degree in related area.
• Clinical Trial Professional certification from a professional society within one year in position.
• Minimum of 1 year Lead/Supervisory/Manager experience.
• Minimum of 3 years of related experience.
• At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment.
• Adaptable to quickly changing priorities.
• Demonstrated skills in employee supervision and HR administration.
• Demonstrated experience in training others, particularly in the field of research.
• Critical thinking skills to evaluate issues and identify a potential solution.
• Clear and concise communicator.