Clinical Research Associate II

Minimum Qualifications:Bachelor's degree in a life science-based fieldPrevious work experience as a study coordinator on a clinical trialBilingual in SpanishThree years of job-related experienceGCP, HIPAA, Conflict of Interest training (CITI coursework available, if needed)Excellent written, verbal, and interpersonal communication skillsAttention to detailProficiency in MS Office Suite3+ years of professional experience in a clinical research environmentAuthorization to work in the US with no future restrictionsOccasional project-specific work may take place on weekendsAbility to assess study participants for adverse reactions or complications and manage side effects of study-related drugsEstablish and maintain strong partnerships with subjects to achieve study objectivesDirect acquisition and analysis of laboratory research data following GCP and FDA regulationsPrepare and maintain IRB and regulatory documentation for various projects and consent patients for clinical researchFacilitate constant communication between principal investigators, Co-Is, facilitators, CTRC staff, and patients to address concerns and maximize eligibility and enrollmentMaintain audits, collect/organize/communicate observations, and create written outlines for weekly executive meetingsAssist in preparation of investigator-initiated protocols, IRB submissions, and research budgeting contractsPerform routine monitoring activities ensuring quality control at study visits along with proper documentation and GCPResponsibilities:Interpret, adhere to, and enforce detailed research protocols and regulatory requirements from screening to study close-out. Maintain the Investigator Binder and Subject Binder in a complete and orderly manner, available for audits at any time.Schedule subjects for study procedures; initiate/coordinate drug orders, laboratory procedures, and treatments for patients based on standing protocol orders. Coordinate appointments for subjects with their assigned specific facilitator. Complete CRFs and forms for subject-related costs reimbursement.Adhere to documentation procedures to ensure cGMP and GCP. Implement GCP and HIPAA compliance for all study-related activities.Communicate effectively with team members, research manager, and physicians via oral, written, and teleconferencing for study-related and ancillary activities. Present research findings to the supervisor through verbal and written communications.Maintain confidentiality of patient-related records (HIPAA), including written and verbal communications.Salary:

$32-$38

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