Clinical Research Manager

%

of time

Essential Function (Yes/No )

Key Responsibilities

(To be completed by Supervisor)

20

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 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, Open Clinica, and Apex EMR.

20

Yes

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.

Acts as resource to CRC in study startup. Helps troubleshoot logistics as needed by CRC and helps conduct and attends all relevant SIV meetings with sponsors and external sites. May be required to complete study start-up independently and then train CRC.

15

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.

Work with Clinical Research Manager and CRC team to implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration to improve efficiency, maximize limited resources, and deliver optimal clinical trial experience forpatients and high-quality data.

Field questions, explore issues, and support CRCs in problem solving on the day-to-day level; recognizes trends and discusses with Clinical Research Manager to ensure that trends are addressed on a broad scale.

10

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.

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.

Facilitate start-up and study coordination at external sites for multi-site investigator initiated studies.

20

Monitors and audits visits. Monitors preparation in order to oversee and assist study coordinators in preparing for audits. Ensures 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.

Trains, supervises, and guide CRCs to ensure optimal communication with industry, institutional, external site, and cooperative group monitors and auditors.

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.

5

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.

5

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.

5

Act as backup for CRCs to cover operation as needed, and may have 1-2 patients on study to maintain skills for this difficult trial.

100%