Research Assistant

MemorialCare•Fountain Valley, CA

3d•Onsite

About The Position

Under the direction and supervision of the Director of Clinical Operations, Manager(s) of Clinical Operations and Principal Investigator, the Research Assistant is responsible for providing support for clinical research protocols. The Research Assistant helps facilitate the conduct of one or more clinical research protocols. Duties may include assisting the Principal Investigator (PI) in recruiting patients for the clinical study, obtaining informed consent, enrolling subjects onto the study, participating in study procedures, and conducting follow-up of study participants. The Research Assistant may also assist the study team with the administration and regulatory compliance of assigned clinical research protocol(s). These responsibilities may include providing support with regulatory preparation and maintenance submissions for assigned studies. The Research Assistant is responsible for coordinating study activities according to the protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.).

Requirements

Minimum of one (1) year of clinical research, or relevant experience, required.
Knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) required.
Must maintain a valid driver’s license and automobile insurance as travel to physician offices and health system locations is required for departmental specific job duties.

Nice To Haves

Knowledge of clinical trial federal, state and local regulation requirements preferred.
Familiarity with medical terminology/environment preferred.
Bachelor’s degree in relevant field preferred.
Phlebotomy certification preferred.
Current CITI training preferred.

Responsibilities

Under direct supervision of the Director of Clinical Operations, Manager(s) of Clinical Operations and Principal Investigator, the Research Assistant is responsible for helping enlist, maintain, and assure protocol compliance for all study participants in assigned clinical research protocol(s).
Screens potential participants for protocol eligibility then collaborates with study investigator in determining eligibility of potential participants in assigned clinical research protocol(s).
Presents trial details to the participant, participates in the informed consent process, and enrolls participants in study protocol.
Ensures research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
Responsible for assisting with accurate and timely data collection, documentation, entry, and reporting.
May participate in obtaining required biospecimen samples and transporting to appropriate laboratories for processing then shipping samples externally according to IATA requirements.
Provides a safe environment for study participants and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Be at work and be on time.
Interact in a positive and constructive manner.
Follow company policies, procedures and directives.