This position is for a CRC in the South Bay Area of Los Angeles.
Under the supervision of the Director, TRIO-US Network the Clinical Research Coordinator (CRC) is responsible for identifying potential study patients, appropriate enrollment, ensuring protocol procedures are completed accurately, safely, and in a timely manner, including study patient non-nurse assessments, FDA, IRB and study compliance; additional responsibilities include but are not limited to data management and study coordination; research chart documentation, quality assurance, maintenance of drug records, study report preparation, dissemination of protocol information to health care professionals, patients and their families or guardians. Collection and transcription of study patient data into case report forms; work with study monitors; occasional travel to UCLA and travel between assigned sites as required.
The CRC must be able to travel between sites in the South Bay and be available to occasionally work flexible hours to meet patient needs, study deadlines and priorities. S/He collaborates with the Director, TRIO-US Network, UCLA academic faculty, site staff, and outside partners to help activate, execute, and oversee clinical trials conducted in the TRIO-US Network.
The CRC has responsibility to collaborate and communicate with the TRIO-US Central Administration and the Regulatory Manager regarding study activation and duty execution. S/He collaborates with TRIO-US Central Administration and site research staff and faculty to assist with study execution at the assigned site including but not limited to:
Identify potential study patients and alert investigators at the site.
Meet with site investigator(s) and site clinical staff to review potential and on-study patients, discuss new protocols, patients, and patient treatment issues and to assist the investigator with identifying potential study candidates.
Discuss study timetables and calendars to assure protocol compliance with the site sub-investigators and clinical staff.
Maintain contact with potential patients and on-study patients, answering research/study questions and providing support.
Perform patient registration activities including assist investigators with the informed consent process, the patient meets protocol required pre-treatment and eligibility, register/randomize patients referred for protocol, and document record of patient registration and treatment assignments, coordinate research procedures and collect data.
Assist investigators in coordinating and managing patient care activities according to protocol requirements.
Compile protocol data, including protocol-specific patient logs, screening logs and statistics; assist in the collection and documentation of data when required; collect source documentation (outside physician offices, hospital records, surgery reports, treatment records, pathology, x-ray, operative reports, radiotherapy forms and films) and submit data to sponsoring agency to meet protocol requirements.
Maintain source documents on study patients, including: all clinic notes (physicians, nursing/treatment staff and research staff notes); adverse events and concomitant medication logs, drug accountability records, dosage modifications and treatment calculations.
Maintain Site Study Reference Binders for Network studies, update manuals with protocol amendments, safety reports, study correspondence, investigator brochures and study signature logs.
Assist in quality control and quality assurance activities, including but not limited to a review of study-specific research forms for completeness and accuracy; review completed source documents for protocol compliance; audit information for accuracy and ensure timeliness of data submission; prepare source documentation/research records, drug accountability records and study reference binders for monitoring visits.
Attend Network staff meetings and other meetings as required.
Alert investigators and appropriate site personnel and Central Administration of study information/correspondence/MedWatch IND Safety Reports regarding adverse drug reaction reports (SAE's), and potential treatment complications.
Manage source data verification (SDV) with monitors including study documentation, drug accountability and study records review with study monitors, auditors, or central administration staff.
Periodically review investigational drug logs and perform investigational drug inventories with site pharmaceutical services or treatment staff to assure accurate drug accountability documentation and protocol compliance.
Provide coverage at other Network locations as needed.
Prepare communications, memos, and other information regarding recent studies, protocol amendments, safety data/IND safety reports, monitor letters, protocol enrollment notices to investigators, nurses, and staff.
Function as liaison between other hospitals, clinics, departments, and services (Surgery, Radiology, Clinical Labs, Pathology, regarding coordination of research patient care and data collection.
Serve as liaison between study sponsors, regulatory agencies (FDA, UCLA/TRIOI Central Investigational Drug Pharmacies and local/central IRBs.
Triage patient phone calls and refer to appropriate resources for resolutions of problems, issues, or questions.
Participate in continuing education activities, presentations or seminars related to data management, cancer, and other areas to improve knowledge for job performance.
Attend Investigator's meetings, TRIO-US Network trainings, and other conferences as required.
The Director, TRIO-US Network or Chief Operating Officer (COO) may assign additional work and/or change the CRC assignments to ensure studies and patient care needs are managed appropriately and in a timely manner. This position is currently a hybrid position depending on the business of the clinic(s) and patient load. This position may convert over time to an entirely in-person position.
Bachelor’s degree or at least 7 years’ experience in clinical research
Five years of experience as a clinical research coordinator or two years of experience in oncology focused clinical research coordination .
Experience in collaborating with faculty and staff on clinical trials.
Experience with clinical research systems: eRegulatory platforms, EDC, and CRMS.
Working knowledge of policies and procedures that govern clinical research, including but not limited to FDA regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA).
Skills & Abilities:
Knowledge and experience in managing clinical trials.
Knowledge of regulatory guidelines and requirements for the conduct of clinical trials and research subject protection.
Knowledge and experience in the clinical research environment.
Knowledge of quality and performance improvement methodologies, safety, and reliability science.
Skilled in communicating effectively, facilitating group processes and training staff.
Ability to establish and maintain effective and productive /working relationships with all employees, in a variety of organizations.
Ability to work under pressure and to maintain efficiency and composure.
Exceptional customer service and people skills.
Good judgment and decision-making abilities.
Excellent verbal and written communication skills.
Attention to detail.
Ability to work independently within a defined strategy.
Comfortable in handling challenging situations that may involve adverse outcomes.
The Translational Research in Oncology-US, Network (TRIO-US) is an organization with a long-standing history of providing innovative cancer research in the community, beyond the walls of large academic medical centers and big cities. TRIO-US is a site management organization (SMO) of committed oncologists across the United States interested in offering their patients opportunities to participate in research of novel cancer therapies, while staying close to home. TRIO-US has more than 14 participating community oncology practices from California to Florida
We base our research efforts on therapies targeted to cancer to minimize side effects and focus more directly on the cancer. We work to get early phase studies to patients in their communities to reduce the burden on traveling to large cities or academic medical centers. This helps not only the patients but allows for the faster progress of cancer research by quickly reaching more people. It also allows for us to offer research in a more inclusive way, by extending research to communities that may be underserved or underrepresented in clinical trials, offering potentially better cancer care options.
It is because of th...e participation of the thousands of patients, their committed clinicians and support systems that TRIO-US has been able to develop and offer important research that led to many new therapies for breast, kidney, lung, and colorectal cancers.