Research Assistant

The Research Assistant (RA) supports the activities, duties, and procedures required for the start-up, conduct, and close-out of oncology clinical trial protocols. Working under the direction of a Clinical Research Coordinator (CRC) or Team Lead, the role helps obtain clean, objective, and accurate data within sponsor timelines while protecting participant safety and maintaining inspection-ready documentation.

Two things distinguish this role beyond standard clinical support. Oncology protocols are clinically dense, so building real familiarity with the state of the disease, treatment history, and clinical rationale behind each assigned protocol - not just the task list - is part of the job from day one. In this patient population, a missed detail is a safety issue before it is ever a data issue. The care model is white-glove: participants and their families are never routed around or told no when they hit a logistical obstacle, and the RA is expected to help remove those barriers, escalating to the CRC or Team Lead when a resolution is beyond their current scope.

This is the individual contributor entry point into the Clinical Research Coordinator job family. The band spans Research Assistants who are new to clinical research through Senior Research Assistants operating with greater independence and taking on more complex protocol responsibilities. Progression through the band, and eventual readiness for the CRC role, is determined by the company's CRC Competency Assessment.

All work is performed in accordance with company SOPs, policies, and procedures, federal regulations, medical ethics, Good Clinical Practice (GCP), ICH guidelines, IRB requirements, sponsor protocol requirements, and company Core Values, Mission Statement, and Employee Manual.

Essential Job Functions

• A. Read and understand protocols to help accomplish protocol-specified patient visits and procedures as directed by the assigned Team Lead or CRC.
• B. Under the direction of the assigned Team Lead or CRC and after completion of required training, clearly and concisely document patient assessments, observations, test results, and other study-related information per federal regulations, protocol requirements, and GCPs.
• C. Obtain patient informed consent according to federal regulations, GCPs, and IRB requirements.
• D. Assist in the creative and diligent recruitment of qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor's timeline while following regulations and rules governing medical ethics, IRB, and GCP guidelines.
• E. Assist in the scheduling, preparation, and conducting of patient visits according to protocol requirements and timelines as directed by the assigned Team Lead or CRC.
• F. Under close supervision, maintain accurate and complete written source documentation of patient visits and protocol-related activities.
• G. Accurately complete case report forms (CRFs) and/or worksheets generated by the sponsor or CRO.
• H. Maintain confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements, including but not limited to those with the company, between the company and sponsors, and between the company and other entities.
• I. Promptly report adverse events to the Team Lead, CRC, or other supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.
• J. Assist in the accountability of clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and help ensure availability of appropriate quantities required for the study.
• K. Maintain ongoing communication with the Team Lead, CRC, Clinical Team Manager, Principal Investigator, and other persons assisting with the study, and document these communications according to protocol requirements and company policies.
• L. Attend required training courses/conferences to stay current and aware of changing federal regulations and company policies.
• M. Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
• N. Perform all study-related duties in a time- and cost-effective manner in adherence with company policies.
• O. Perform all duties in a safe and prudent manner.
• P. Represent the organization in a professional and courteous manner (verbal, written, and in appearance) when interacting with internal staff, sponsors, IRBs, patients/subjects, and nursing and medical staff members of various clinics, hospitals, and physicians' offices.
• Q. Additional duties as assigned by management.

The Research Assistant (RA) supports the activities, duties, and procedures required for the start-up, conduct, and close-out of oncology clinical trial protocols. Working under the direction of a Clinical Research Coordinator (CRC) or Team Lead, the role helps obtain clean, objective, and accurate data within sponsor timelines while protecting participant safety and maintaining inspection-ready documentation.

Two things distinguish this role beyond standard clinical support. Oncology protocols are clinically dense, so building real familiarity with the state of the disease, treatment history, and clinical rationale behind each assigned protocol - not just the task list - is part of the job from day one. In this patient population, a missed detail is a safety issue before it is ever a data issue. The care model is white-glove: participants and their families are never routed around or told no when they hit a logistical obstacle, and the RA is expected to help remove those barriers, escalating to the CRC or Team Lead when a resolution is beyond their current scope.

This is the individual contributor entry point into the Clinical Research Coordinator job family. The band spans Research Assistants who are new to clinical research through Senior Research Assistants operating with greater independence and taking on more complex protocol responsibilities. Progression through the band, and eventual readiness for the CRC role, is determined by the company's CRC Competency Assessment.

All work is performed in accordance with company SOPs, policies, and procedures, federal regulations, medical ethics, Good Clinical Practice (GCP), ICH guidelines, IRB requirements, sponsor protocol requirements, and company Core Values, Mission Statement, and Employee Manual.

Essential Job Functions

• A. Read and understand protocols to help accomplish protocol-specified patient visits and procedures as directed by the assigned Team Lead or CRC.
• B. Under the direction of the assigned Team Lead or CRC and after completion of required training, clearly and concisely document patient assessments, observations, test results, and other study-related information per federal regulations, protocol requirements, and GCPs.
• C. Obtain patient informed consent according to federal regulations, GCPs, and IRB requirements.
• D. Assist in the creative and diligent recruitment of qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor's timeline while following regulations and rules governing medical ethics, IRB, and GCP guidelines.
• E. Assist in the scheduling, preparation, and conducting of patient visits according to protocol requirements and timelines as directed by the assigned Team Lead or CRC.
• F. Under close supervision, maintain accurate and complete written source documentation of patient visits and protocol-related activities.
• G. Accurately complete case report forms (CRFs) and/or worksheets generated by the sponsor or CRO.
• H. Maintain confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements, including but not limited to those with the company, between the company and sponsors, and between the company and other entities.
• I. Promptly report adverse events to the Team Lead, CRC, or other supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.
• J. Assist in the accountability of clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and help ensure availability of appropriate quantities required for the study.
• K. Maintain ongoing communication with the Team Lead, CRC, Clinical Team Manager, Principal Investigator, and other persons assisting with the study, and document these communications according to protocol requirements and company policies.
• L. Attend required training courses/conferences to stay current and aware of changing federal regulations and company policies.
• M. Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
• N. Perform all study-related duties in a time- and cost-effective manner in adherence with company policies.
• O. Perform all duties in a safe and prudent manner.
• P. Represent the organization in a professional and courteous manner (verbal, written, and in appearance) when interacting with internal staff, sponsors, IRBs, patients/subjects, and nursing and medical staff members of various clinics, hospitals, and physicians' offices.
• Q. Additional duties as assigned by management.

*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.