Clinical Research Coordinator - Thoracic & Sarcoma Oncology

UCSF•San Francisco, CA

3d•$40 - $65

About The Position

The Clinical Research Coordinator works independently or with general direction at the fully operational journey level to execute, manage, and coordinate clinical research protocols under the direction of the Clinical Research Manager and Principal Investigator (PI). The role may coordinate data collection and operations for several concurrent studies, depending on their size and complexity, in accordance with research protocols and UCSF and regulatory agency policies. The coordinator supports study initiation and operations, including subject recruitment, screening, enrollment, visits, follow-up, and communication with patients and clinical teams. The role manages study data, databases, source documentation, specimens, regulatory records, and quality control; reports study progress and results; and helps ensure patient safety, data integrity, and regulatory compliance. The coordinator may also coordinate staff schedules, assist with training and oversight of research staff, and participate in internal and external audits. The position is within the UCSF Helen Diller Family Comprehensive Cancer Center, which integrates laboratory, clinical, patient-care, and population research, guided by precision medicine and precision population health.

Requirements

High school diploma or equivalent experience.
Experience in clinical research, or demonstrated research knowledge or training experience that translates to a clinical research setting.
Familiarity with specimen processing.
Working knowledge of federal, state, and local research regulations and guidelines, and research practices in a laboratory or clinical setting.
Attention to detail; strong interpersonal skills; and effective verbal and written communication skills for coordinating with participants, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment while working 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.
Experience with computer programs such as Microsoft Office and internet-based databases, and specialized software such as OnCore.
Ability to sit and work at a computer for several hours per day and stand for several hours per day; ability to travel between campuses via UCSF shuttle as needed.
Ability to apply relevant information to assess, interpret, and process medical data.
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, a sensitive patient population.

Nice To Haves

Knowledge of clinical research in breast oncology.
Knowledge and experience managing oncology clinical trials.
Analytical and writing skills in a science or research environment.
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 participation.
Experience with electronic medical records.
Knowledge of UCSF and departmental policies concerning reimbursement, research guidelines, confidentiality, HIPAA, patient safety, and research practices.
Knowledge of medical terminology; research policies and guidelines; infectious-substance packing and shipping guidelines; database building and analysis; and data management using tools such as Access, Stata, SAS/SPSS, or Teleform.
Membership in a clinical research professional society.
Experience applying Good Clinical Practice Guidelines, HIPAA, human research subject protections, CHR recruitment and consent regulations, effective cash-handling procedures, Environmental Health and Safety Training, and Fire Safety Training.

Responsibilities

Work with the PI, Clinical Research Manager, and research team to identify potential subjects, develop recruitment and retention strategies, and screen and enroll participants.
Prepare protocols for initiation in accordance with applicable research regulations, guidelines, and cancer center clinical practices.
Schedule study visits; administer questionnaires; collect medical histories; and perform study procedures.
Maintain communication and rapport with participants, support retention, arrange follow-up appointments, and coordinate continuity of care with providers.
Review study information with participants and advocate for patient safety throughout protocol procedures.
Oversee subject billing and reimbursements and resolve discrepancies.
Coordinate study procedures with clinic staff, other studies, technicians, and affiliated groups to support scheduling efficiency and patient safety.
Assess and recommend improvements to patient coordination, data collection, data management, protocol adherence, and study collaboration.
Provide clinical staff with protocol-specific information, including study-drug and patient-care information, under the supervision of the PI, investigators, and Clinical Research Manager.
Suggest study-process modifications to improve efficiency.
Review medical charts and electronic records to extract study information and data.
Collect and enter data from visits, procedures, laboratory tests, and follow-up in a timely manner.
Manage protocol databases, update or create databases, respond to database queries, and maintain subject tracking systems.
Create and maintain study source documentation, sample tracking, data collection forms, comprehensive datasets, procedure manuals, and other protocol records.
Work with the supervisor to maintain accurate study and internal database records, including OnCore, and analyze data as it becomes available.
Use sponsored-study databases and systems including OnCore, iMEDris, and Apex EMR.
Oversee data integrity and assess policies and procedures for recruitment, data collection, and data management; implement periodic quality-control procedures.
Ensure specimens are processed, stored, and shipped according to laboratory policies and safety requirements; coordinate specimen exchanges and transport; and maintain sample integrity and security.
Ensure sample-derived data is entered into the appropriate databases and reviewed by the investigator.
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 events, and protocol violations; maintain regulatory documents and monitor submission timelines.
Document adverse events and submit them to appropriate departments while protecting patient confidentiality.
Participate in and prepare documentation for internal and external audits or protocol reviews.
Assist with training staff and peers on protocols, procedure changes, data collection and entry, database processes, chart review, and record storage.
Attend and participate in team meetings and professional development opportunities.
Participate in staff-wide assignments, including filing, maintaining study supplies and shared office and laboratory spaces, and developing policies and procedures.
Perform other duties as assigned by the Clinical Research Manager, PI, and Research Personnel Manager.