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Job Objective: A brief overview of the position.
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- Responsible for coordination and implementation of clinical research activities. Coordinates and quality controls the development and maintenance of clinical research studies, ensuring compliance with IRB requirements and all related laws, regulations, policies, and guidelines. Provides day-to-day technical leadership and support to associates engaged in the execution of multiple, complex research protocols. Provides administrative assistance of the research activity and participates in the formulation and implementation of operating strategies and policies, protocols, systems, and procedures
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Reports to
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- Manager, Research and Clinical Trials
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Supervises
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- Non-exempt research staff
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Ages of Patients
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- Adult
- Geriatric
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Blood Borne Pathogens
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- Minimal/No Potential
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Qualifications
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Education
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- Required: Bachelors degree in healthcare and/or related field
- Preferred: Masters degree
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Licensure/Certification
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- Required: Completion of CITIProgram.org courses: Good Clinical Practice (GCP) Course, Clinical Research Coordinator Foundations, Clinical Research Coordinator Advanced.
- Preferred: https://acrpnet.org/ CCRC certification or www.socra.org CCRP Certification. Certification required upon eligibility
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Experience
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- Required: Three (3) years current experience in medical center, research institute, Biotech/CRO and/or healthcare related positions
- Preferred: Previous experience with clinical trials
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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. Recruit, educate, consent, schedule, and complete follow-up with patients/subjects.
3. Participate in the training and supervision of research staff; provide research staff with protocols and guidance on SOPs to ensure consistency and compliance with policies and processes.
4. Perform pre-investigation, initiation & periodic monitoring visits to assure that the protocol, obligations, responsibilities, and regulations are established & followed.
5. Monitor subject records for quality, data integrity, & compliance with regulations and organization’s SOPs.
6. Assist in writing and/or auditing clinical reports.
7. Assist in developing protocols, case report forms, and informed consent documents.
8. Work closely and act as a liaison between sponsors, Contract Research Organization (CRO) sites and other department staff members.
9. Manage the negotiation & monitoring of budgets and contracts. Formulate study budgets utilizing the protocol, manuals, study plan and resource needs assessment for the study. Develop and support the development of tools and training to aid in the development of study budgets, coverage analysis, tracking of invoiceable term items and research billing.
10. Perform clinical site activities (regulatory issues, patient accrual, patient scheduling & care coordination, data capture & monitoring, adverse events reporting).
11. Develop sufficient service/ program / product / indication expertise to communicate directly with clinicians, staff, other departments, consultants and provide consultation/expert advice to leadership.
12. Develop or contribute to the development of SOPs, best practices, tools, processes and training to enhance safety and compliance with federal, local and institutional regulations/guidelines.
13. Manage tracking & reporting Serious Adverse Events (SAEs) and Adverse Events (AEs).
14. Work with physicians & leadership to develop & implement client trials and research programs. Carries out key activities in evaluating, initiating, operationalizing and conducting clinical trials.
15. Work closely with physicians and staff to facilitate research and enrollment to research studies and clinical trials.
16. Prepare and present materials to Institutional Review Board (IRB). Investigates and resolves problems and complaints; develops corrective and preventative action plans.
17. Data Management – knowledge of computer systems to support case report forms completion.
18. Develop educational/promotional materials to educate patients on available programs and clinical trials. Develop & maintain a formal mechanism to ensure that information about the availability of clinical trials is provided to patients.
19. Work to accrue and monitor cases enrolled in program and clinical trials; report to governing Committee.
20. Coordinate performance improvement activities as they relate to clinical trials and research.
21. Provides support to investigators and maintain screening, enrollment, compliance, statistics on program and trials. Involved in planning long or short term objectives that support research program.
22. Develops and implements Education Program for the community, including materials and lectures.
23. 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.
