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LVN-Clinical Research Associate

Company: Eisenhower Health
Location: Rancho Mirage
Posted on: June 11, 2021

Job Description:



Full Time,Varies,8 Hour Shift

Job Objective: A brief overview of the position. The position will be responsible for assisting in the running of Clinical Trials in the Oncology field.

Reports to Director, Research Administration

Supervises N/A

Ages of Patients Adult


Blood Borne Pathogens High potential

Qualifications Education Required: BA/BS Degree or in lieu 2-3 years experience

Preferred: Degree in Clinical Research, Nursing or Administration

Licensure/Certification Required: California LVN license and SOCRA or ACRP certification upon eligibility

Preferred: ACRP or SOCRA certification

Experience Required: 1-2 years experience in the Healthcare industry

Preferred: 2 years in research, some experience in Oncology

Essential Responsibilities Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.

Complete clinical trial feasibility questionnaires.

Work with in-house general counsel and sponsor on Clinical Trial Agreement.

Work with finance to develop budget for clinical trial.

Recruit, screen, and consent patients for study.

Coordinate completion of pre and post-registration/randomization tests and exams.

Obtain, prepare (centrifuge) and ship biological specimens.

Document and report adverse events.

Schedule and monitor patient study visits per study calendar.

Ensure source documents are complete in order to complete Case Report Forms (CRFs).

Enter data into sponsor’s electronic data capture (EDC); monitor data and respond to queries.

Coordinate, prepare for and participate in monitoring visits and audits. Have regulatory and patient study files in a continuous state of readiness for audit.

Order study supplies and investigation agents as needed.

Coordinate investigational drug accountability with pharmacy.

Administer, dispense investigational agent.

Interact with physicians, study sponsor, IRB and clinic staff.

Complete paperwork for initial protocol review and submission to IRB.

Prepare and submit IRB forms for amendments, non-local adverse events, annual review.

Maintain investigator files, regulatory files and patient study binders.

Create and track invoices during study.

Track study budget and payments.

Schedule meetings with physicians, create agendas, and take minutes.

Send letters and/or telephone patients and physicians regarding study results.

Perform other duties as assigned.

Keywords: Eisenhower Health, Apple Valley , LVN-Clinical Research Associate, Other , Rancho Mirage, California

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