Clinical Research Coordinator - Thoracic & Sarcoma Oncology

University of California, San Francisco•San Francisco, CA

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 clinical research studies, depending on their size and complexity, and supports research activities in Thoracic & Sarcoma Oncology at the UCSF Helen Diller Family Comprehensive Cancer Center. The coordinator works with investigators, clinical and research teams, study participants, departments, and collaborating institutions to support study initiation and conduct, participant recruitment and retention, visits and procedures, data and specimen management, regulatory compliance, reporting, and quality control. The role also helps train research staff, contributes to team activities, and performs other duties as assigned.

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 practice methods in a laboratory or clinical setting.
Attention to detail; strong interpersonal skills; and effective verbal and written communication skills for coordinating with subjects, 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.
Prior experience with computer programs such as Microsoft Office and internet-based databases, and specialized software such as OnCore.
Ability to apply relevant information to the assessment, interpretation, and processing of 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.
Ability to sit and work at a computer for several hours per day and stand for several hours per day; may need to travel between one or more campuses via UCSF shuttle.

Nice To Haves

Knowledge of clinical research in breast oncology.
Knowledge and experience managing oncology clinical trials.
Prior analytical and writing skills in a science or research environment.
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 while assessing what is realistic and appropriate for patient participation.
Experience with electronic medical records.
Knowledge of UCSF and departmental policies related to reimbursement, research guidelines, confidentiality, HIPAA, patient safety, and the UCSF mission and research purpose.
Knowledge of medical terminology; research policies and guidelines; requirements for packing and shipping infectious substances; and database building, analysis, and data management using tools such as Access, Stata, SAS/SPSS, and Teleform programming platforms.
Membership in a clinical research professional society.
Experience applying Good Clinical Practice Guidelines, HIPAA, the Protection of Human Research Subjects, 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 subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
Prepare protocols for initiation, including applying relevant research regulations, guidelines, and clinical practice methods.
Schedule study visits; administer questionnaires, collect medical histories, and perform study procedures.
Maintain communication and rapport with study subjects, address their needs, arrange follow-up appointments, and serve as an intermediary; discuss study outcomes with providers to support continuity of care.
Review study information with subjects and advocate for patient safety throughout protocol procedures.
Oversee subject billing and reimbursements and resolve discrepancies and issues.
Coordinate with study and clinic staff to ensure study procedures are completed, and coordinate with other studies, technicians, and affiliated groups to support scheduling efficiency and patient safety.
Recommend improvements to patient coordination, data collection and management, protocol adherence, study collaboration, and study processes.
Help educate clinical staff about protocol-specific clinical care and study information, including study drugs, under the supervision of the PI, investigators, and Clinical Research Manager.
Review medical charts and electronic records to extract medical information and study data.
Collect and enter data from subject visits, procedures, laboratory tests, and follow-up activities into databases in a timely manner.
Manage protocol database structures, update existing databases, create new databases as needed, and maintain subject tracking systems.
Create and maintain study source documentation, data collection forms, comprehensive datasets, and tracking records for samples and protocol activities.
Respond to database queries and analysis requests; work with the supervisor to maintain accurate data in study and internal databases, including OnCore, and analyze data as it becomes available.
Use data collection and reporting systems, including sponsored-study databases, OnCore, iMEDris, and Apex EMR.
Oversee data integrity, assess recruitment and data policies and procedures, maintain procedure manuals, ensure consistency in data collection and entry, and implement periodic quality-control procedures.
Ensure specimens are processed, stored, and shipped according to laboratory policies and safety measures; coordinate specimen exchanges and transport with collaborating investigators and staff.
Oversee incoming sample data, ensure it is entered correctly into databases and reviewed by the investigator, and maintain specimen 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, healthcare providers, studies, and departments.
Participate in and cooperate with internal and external audits or protocol reviews and prepare required documentation.
Assist with training staff, peers, and others on research protocols, procedure changes, data collection and entry, databases, chart review, and related procedures.
Attend and actively participate in team meetings and professional development opportunities.
Participate in staff-wide assignments, 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 Clinical Research Manager, PI, or Research Personnel Manager.