Clinical Research Coordinator - Cancer Immunotherapy Research & Clinical Translation

UCSF•San Francisco, CA

3d•$40 - $65

About The Position

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) seeks a Clinical Research Coordinator (CRC) for the Cancer Immunotherapy Research & Clinical Translation (CIRCT) Program within the Division of Hematology/Oncology. The CRC independently executes, manages, and coordinates research protocols under the direction of the Clinical Research Manager and/or Principal Investigator (PI), coordinating operations and data collection for concurrent clinical research studies in accordance with protocols and UCSF and regulatory agency policies. The role supports sponsored, cooperative group, and investigator-initiated studies of varying size and complexity. The CRC coordinates study activities across services and departments; oversees data and specimen management; manages and reports study results; creates and maintains databases, datasets, and reports; assists with training Assistant CRCs; supports regulatory compliance and documentation; monitors data integrity and quality control; obtains necessary UCSF approvals; reports study progress to investigators; and participates in audits and protocol reviews. The position works with investigators, research and clinic staff, and study participants to identify, screen, and enroll subjects; coordinate study visits and procedures; support patient safety, communication, and retention; and provide protocol information to clinical staff and patients. It also includes medical record review, timely data entry and follow-up, database maintenance, specimen processing and shipment coordination, and regulatory submissions and reporting. The program has a broad portfolio of clinical trials and aims to provide streamlined access to cancer therapies and compassionate, patient-centered care while improving outcomes.

Requirements

High school diploma or equivalent experience or training.
Experience in clinical research, or demonstrated research or training experience that translates to a clinical research setting.
Experience with medical charts and electronic records.
Ability to sit and work at a computer for several hours per day and to stand for several hours of the day; may need to travel between campuses via UCSF shuttle.
Familiarity with specimen processing or demonstrated ability to learn specimen processing in a laboratory environment.
Working knowledge of, or ability to learn, federal, state, and local research regulations and guidelines and research practices in a laboratory or clinical setting.
Ability to independently interpret and apply policies, respond to requests, resolve issues, and assist faculty and staff at all levels in a team-oriented environment.
Ability to work with oncology patients and other sensitive patient populations.
Ability to work across several programs and report to two or three supervisors.
Attention to detail; strong interpersonal skills; effective verbal and written communication; ability to coordinate with subjects, team members, departments, and outside institutions; and ability to multitask in a fast-paced environment with a diverse subject population.
Ability to work independently, complete projects on time, and prioritize multiple projects to meet deadlines.
Demonstrated knowledge and understanding of research, especially biological sciences.
Exceptional database management experience and experience with computer programs such as Microsoft Office and internet-based databases, including specialized software such as OnCore.

Nice To Haves

Bachelor's degree with a major in science or a related field.
Prior analytical and writing skills in a science or research environment.
Knowledge of clinical research in oncology.
Knowledge and experience managing oncology clinical trials, including Phase I–III trials.
Membership in a clinical research professional society.
Fluency with the Committee of Human Research (CHR) online iMEDris system for protocol submission, renewal, and modification.
Understanding of the patient population and ability to build rapport while assessing realistic and appropriate patient participation.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
Knowledge of UCSF and departmental policies for reimbursement, research, confidentiality, HIPAA, patient safety, and medical-record handling; knowledge of medical terminology, research policies and guidelines, and requirements for packing and shipping infectious substances; and database building, analysis, and data management experience with platforms such as Access, Stata, SAS/SPSS, and Teleform.
Experience applying Good Clinical Practice Guidelines, HIPAA, protections for human research subjects, CHR recruitment and consent regulations, Effective Cash Handling Procedures, Environmental Health and Safety Training, and Fire Safety Training.

Responsibilities

Coordinate and implement clinical research studies with the PI, Lead CRC, research team, clinical staff, and affiliated groups.
Identify, screen, and enroll subjects; develop recruitment and retention strategies; schedule study visits and follow-up appointments; administer questionnaires; collect medical histories; and perform study procedures.
Maintain communication and rapport with study participants, address their needs, support retention, review study information, and advocate for patient safety throughout protocol procedures.
Oversee subject billing and reimbursements and resolve discrepancies or related issues.
Coordinate study procedures and scheduling with study, clinic, and laboratory staff; communicate protocol and study-drug information to clinical staff and patients under investigator and Lead CRC supervision.
Identify opportunities to improve patient coordination, data collection, data management, protocol adherence, collaboration, and study efficiency.
Review medical charts and electronic records and extract information for research studies.
Collect and enter data from visits, procedures, laboratory tests, and follow-up into study and internal databases in a timely manner; respond to database queries and support analysis and reporting.
Manage and improve protocol databases; create new databases as needed; maintain subject tracking systems, data collection forms, source documentation, procedure manuals, and comprehensive datasets.
Use and maintain study databases and systems including sponsored-study databases, OnCore, iMEDris, and Apex EMR; work with the supervisor to ensure complete and accurate data.
Oversee data integrity and implement periodic quality-control procedures for recruitment, data collection, and data management.
Ensure specimens are properly processed, stored, and shipped according to laboratory policies and safety requirements; coordinate specimen exchange and transport; and safeguard sample integrity and security.
Ensure sample-related data is correctly entered into databases and reviewed by the investigator.
Support compliance with the Code of Federal Regulations, Good Clinical Practice, UCSF regulations, and other applicable research requirements.
Initiate and follow up on iMEDris submissions for single-patient exceptions, adverse-event reporting, and protocol violations; maintain regulatory documents and submission timelines; document and report adverse events.
Protect patient confidentiality when communicating with agencies, healthcare providers, study teams, and outside departments; prepare documentation for and participate in internal and external audits or protocol reviews.
Assist with training staff and peers on protocols, procedure changes, data collection and entry, databases, medical chart review, and record storage.
Attend team meetings and professional-development opportunities; contribute to staff-wide assignments, including filing, maintaining study supplies and shared office and laboratory spaces, and developing policies and procedures.
Perform other duties as assigned.