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Job Objective: A brief overview of the position.
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• The position is responsible for supporting investigator(s) with clinical trials and research.
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Reports to
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• Manager, Research and Clinical Trials
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Supervises
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N/A
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Ages of Patients
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Adult
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Geriatric
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Blood Borne Pathogens
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Moderate Potential
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Qualifications
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Education
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• Required: BA/BS Degree (2 years’ research experience may be substituted)
• Preferred: Degree in Clinical Research, Nursing, Administration or relevant field.
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Licensure/Certification
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• Required: Completion of CITI Good Clinical Practice (GCP) for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course (www.CITIprogram.org)
• Required: SOCRA or ACRP certification upon eligibility
• Preferred: ACRP or SOCRA certification
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Experience
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- Required: 1-2 years’ experience in the Healthcare industry
- Preferred: Clinical Trials experience
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Essential Responsibilities
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1. Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
2. Completes patient recruitment & screening for eligibility to protocol. Documents results. Completes registration/randomization for eligible patients.
3. Coordinates and schedules all evaluations, treatment, exams, specimen collection, etc. per protocol.
4. Data management: Using Epic EHR, documents and abstracts ALCOA-C source. Contacts patients, as needed, to collect data. Enters data into case report form (CRF), electronic data capture systems (EDC).
5. Regulatory compliance: Maintains investigator site file (ISF) and trial master file (TMF). Submits amendments, AEs, SAEs, reports, etc. to IRB, sponsor and administration.
6. Communicates with investigators, sponsors, monitors/auditors, IRB and leaders
7. Schedules meetings with physicians, creates agendas, and takes minutes.
8. Completes research billing review in Epic. Reviews coverage analysis and budget with finance and research team. Assists accounting with invoicing.
9. Performs other duties as assigned.
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Located in the heart of the Coachella Valley, you have access to resort-style living and world-class amenities throughout Southern California.
