Clinical Research Coordinator - Cancer Immunotherapy Research & Clinical Translation

University of California, San Francisco•San Francisco, CA

About The Position

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Clinical Research Coordinator (CRC) to join 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). The role coordinates operations and data collection for several concurrent clinical research studies in accordance with study protocols and UCSF and regulatory agency policies. The CRC supports single or multiple sponsored, cooperative group, and investigator-initiated studies, depending on their size and complexity. Duties include coordinating study activities, serving as an intermediary among services and departments, overseeing data and specimen management, managing and reporting study results, creating and maintaining databases and datasets, assisting with staff training, supporting regulatory compliance, maintaining data integrity and quality controls, obtaining institutional approvals, maintaining regulatory documents, reporting progress to investigators, and participating in audits and protocol reviews. The Cancer Immunotherapy Research & Clinical Translation program is a fast-paced program with a broad portfolio of clinical trials. The UCSF HDFCCC Oncology Program aims to provide patients and families streamlined access to cutting-edge cancer therapies. Its clinicians and researchers provide compassionate, patient-centered care and work to improve outcomes for all patients.

Requirements

High school diploma or equivalent experience/training.
Experience in clinical research, or demonstrated research or training experience that translates into 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 per day.
Ability to travel between one or more campuses via UCSF shuttle as needed.
Familiarity with specimen processing, or demonstrated ability to learn specimen processing in a laboratory environment.
Working knowledge of, or demonstrated ability to learn, federal, state, and local research regulations and guidelines and research practice methods 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 across several programs while reporting to two or three supervisors.
Attention to detail; strong interpersonal skills; effective verbal and written communication skills; and ability to coordinate with subjects, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment with a diverse subject population, 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 prior experience with computer programs such as Microsoft Office and internet-based databases, as well as 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 using the Committee of Human Research (CHR) online iMEDris system for protocol submissions, renewals, and modifications.
Understanding of the patient population and ability to build rapport and assess what is realistic and appropriate for patient participation.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
Knowledge of UCSF and departmental policies concerning reimbursement, research guidelines, confidentiality, HIPAA, patient safety, and the UCSF mission and purpose for research.
Knowledge of medical terminology, research policies and guidelines, infectious-substance packing and shipping guidelines, database building and analysis, and data management using platforms such as Access, Stata, SAS/SPSS, and Teleform.
Experience applying Good Clinical Practice Guidelines; the Health Information and Accountability Act (HIPAA); protections for human research subjects; CHR regulations for recruitment and consent; effective cash-handling procedures; Environmental Health and Safety training; and Fire Safety training.

Responsibilities

Work with the PI, Lead CRC, and research team to identify potential subjects; develop recruitment and retention strategies; and screen and enroll study subjects.
Prepare protocols for initiation, including applying relevant research regulations, guidelines, and cancer center clinical practice methods.
Schedule study visits; administer questionnaires; collect medical history; and perform study procedures.
Maintain communication and rapport with subjects, respond to their needs, arrange follow-up appointments, and serve as an intermediary for them.
Discuss study outcomes with providers to support continuity of care and advocate for subject safety throughout protocol procedures.
Oversee subject billing and reimbursements and resolve discrepancies or issues in a timely manner.
Coordinate with study and clinic staff to ensure study procedures are completed, and work with other studies, technicians, and affiliated groups to improve scheduling efficiency and patient safety.
Identify needs and recommend enhancements to patient coordination, data collection and management, protocol adherence, and study collaboration; suggest process modifications to improve efficiency.
Under the supervision of the PI, investigators, and Lead CRC, educate clinical staff about protocol-specific clinical care and study drugs, and help provide study information to staff and patients.
Review medical charts and electronic records to extract study information and other data.
Collect, enter, report, and manage data from visits, procedures, lab tests, and follow-up in a timely manner.
Manage and update protocol databases, create new databases as needed, maintain subject tracking systems, and create comprehensive datasets as requested by the Lead CRC and/or PI.
Create and maintain study source documentation, data collection forms, sample tracking, and documentation of other protocol activities.
Respond to database queries and analysis requests in a timely manner; work with the Supervisor to maintain accurate study and internal database records and analyze available data.
Use data collection and reporting systems, including sponsored-study databases, OnCore, iMEDris, and Apex EMR.
Oversee data integrity, assess the adequacy of recruitment, data collection, and data management policies and procedures, and maintain a procedure manual to ensure consistent data collection and entry.
Implement and maintain periodic quality-control procedures.
Ensure specimens are processed, stored, and shipped in accordance with laboratory policies and safety measures; arrange specimen exchanges and transport with collaborating investigators and staff.
Oversee data interpreted from samples, ensure it is entered correctly into databases and reviewed by the Investigator, and maintain sample integrity and security.
Ensure studies comply with the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Initiate and follow up on iMEDris submissions for single-patient exceptions, adverse-event reporting, and protocol violations; maintain regulatory documents and monitor data-submission timelines.
Document adverse events and submit them to appropriate departments; protect patient confidentiality when communicating with agencies, providers, studies, and other departments.
Participate in and cooperate with internal and external audits and protocol reviews, and prepare necessary documentation.
Assist the Supervisor in training staff, peers, and others on protocols, procedure changes, data collection and entry, databases, medical-chart review and storage, and other procedures.
Attend and actively participate in regular team meetings and professional development opportunities.
Participate in staff-wide assignments outside protocol management, including filing, cleaning and maintaining study supplies and shared office and laboratory spaces, and developing policies and procedures.
Perform other duties as assigned by the CRM, Principal Investigator, and Research Personnel Manager.