Title: Research Assistant

Location: Fountain Valley

Department: Research Admin

Status: Full Time

Shift: Days

Pay Range*: $23.31/hr - $32.50/hr

MemorialCare is a nonprofit integrated health system that includes four leading hospitals, award-winning medical groups – consisting of over 200 sites of care, and more than 2,000 physicians throughout Orange and Los Angeles Counties. We are committed to increasing access to patient-centric, affordable, and high-quality healthcare; your personal contributions are integral to MemorialCare's recognition as a market leader and innovator in value-based and other care models.

Across our family of medical centers, we support each one of our bright, talented employees in reaching the highest levels of professional development, contribution, collaboration, and accountability. Whatever your role and whatever expertise you bring, we are dedicated to helping you achieve your full potential in an environment of respect, innovation, and teamwork.

Position Summary

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 researchprotocols.DutiesmayincludeassistingthePrincipalInvestigator(PI)inrecruitingpatientsforthe clinical study, obtaining informed consent, enrolling subjects onto the study, participating in study procedures, and conducting follow-up of study participants.

TheResearchAssistantmayalsoassistthestudyteamwiththeadministrationandregulatorycompliance 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 andtrialStandardOperatingProcedures(SOPs),GoodClinicalPractice(GCP)/InternationalConferenceon Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.).

Essential Functions and Responsibilities of the Job

1.UnderdirectsupervisionoftheDirectorofClinicalOperations,Manager(s)ofClinicalOperations andPrincipalInvestigator,theResearchAssistantisresponsibleforhelpingenlist,maintain,and assure protocol compliance for all study participants in assigned clinical research protocol(s).

      2.Screenspotentialparticipantsforprotocoleligibilitythencollaborateswithstudyinvestigatorin determining eligibility of potential participants in assigned clinical research protocol(s).

      3.Presentstrialdetailstotheparticipant,participatesintheinformedconsentprocess,andenrolls participants in study protocol.

      4.EnsuresresearchqualitybypracticingincompliancewithStandardOperatingProcedures(SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.

      5.Responsibleforassistingwithaccurateandtimelydatacollection,documentation,entry,and reporting.

6.May participate in obtaining required biospecimen samples and transporting to appropriate laboratoriesforprocessingthenshippingsamplesexternallyaccordingtoIATArequirements.

7.Provides a safe environment for study participants and study personnel at all times through compliancewithallfederal,state,andprofessionalregulatorystandards.Maintainsstrictpatient confidentiality according to HIPAA regulations and applicable law.

8.Beatworkandbeon time.

9.Interactinapositiveandconstructivemanner.

10.Followcompanypolicies,proceduresanddirectives.

*Placement in the pay range is based on multiple factors including, but not limited to, relevant years of experience and qualifications. In addition to base pay, there may be additional compensation available for this role, including but not limited to, shift differentials, extra shift incentives, and bonus opportunities. Health and wellness is our passion at MemorialCare—that includes taking good care of employees and their dependents. We offer high quality health insurance plan options, so you can select the best choice for your family. And there’s more...Check out our MemorialCare Benefits for more information about our Benefits and Rewards.

Qualifications/Work Experience:

·        Minimum of one (1) year of clinical research, or relevant experience, required.

·        Knowledge of clinical trial federal, state and local regulation requirements preferred.

·        Strong attention to detail required.

·        Familiarity with medical terminology/environment preferred.

·        Knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) required.

Education/Licensure/Certification:

·        Associates degree or equivalent education required.

·        Bachelor’s degree in relevant field preferred.

·        Phlebotomy certification preferred.

·        Current CITI training preferred.

·        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.