What are the responsibilities and job description for the Clinical Research Associate-CPT position at Eisenhower Health?
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Job Objective: A brief overview of the position.
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The position will be responsible for assisting Principal Investigators with the conduct of clinical trials within one or more service lines throughout the health system. As needed, collects specimens by venipuncture, heelstick or fingerstick and delivers samples to lab
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Reports to
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Director, Research Administration
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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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High Potential
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Qualifications
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Education
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Required: BA/BS Degree or in lieu of degree, 2 years clinical trials experience
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Preferred: BA/BS Degree in Clinical Research, Nursing, Administration or Science
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Licensure/Certification
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Required: SOCRA or ACRP certification upon eligibility; California State Certified Phlebotomy Technician; American Heart Association BLS; IATA Compliant Dangerous Goods Training
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Preferred: CCRP Certification from Society of Clinical Research Associates (SOCRA) or CCRC Certification from the Association of Clinical Research Professionals (ACRP)
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Experience
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Required: 1-2 years of experience in the Healthcare industry
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Preferred: 2 years in research in infectious disease, oncology, orthopedics, cardiology, pulmonology, HIV, gastroenterology, primary care, emergency room or diabetes care setting
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Essential Responsibilities
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Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
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Performs tasks delegated by the principal investigator (PI) for clinical trials, including:
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Obtains informed consent
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Facilitates source document completion
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Completes case report form (CRF)
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Gathers documentation to support inclusion and exclusion criteria for trial eligibility
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Documents medication history, concomitant medications and vital signs
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Reviews vital signs, labs, imaging, test results for clinical significance as defined in protocol and reports to PI
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Performs laboratory specimen collection/processing/shipping
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Completes adverse event reporting
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Facilitates accountability and provision of Investigational Product (IP) with pharmacist, nurses and doctors
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Completes regulatory document maintenance
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Works with sponsors and PI on site qualification, readiness and activation tasks for new studies.
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Completes patient screening, recruitment and registration/randomization to protocol.
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Schedules protocol required exams and tests (labs, imaging, EKG, etc.), treatment and specimen collection.
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Completes IRB submissions for regulatory compliance. Reports and communicates to the sponsor and study team.
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Works with finance to facilitate budget development, billing and invoicing and performs patient-level research billing review.
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Schedules regular meetings with PI(s) and study team; creates agendas and takes minutes.
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Asks patient to state name and date of birth and utilizes wristband identification system prior to collection of specimens.
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Collects specimens by venipuncture, heelstick or fingerstick by established protocol and delivers samples to lab in a timely manner.
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Collects, processes, stores and ships specimens per IRB-approved research protocol.
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Complies with hospital and laboratory safety policies and procedures.
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Complies with all state and federal regulations.
- Performs other duties as assigned.
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