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Clinical Trial Associate

  • Permanent
  • Anywhere

Website Southern Illinois Healthcare

Southern Illinois Healthcare

Company : Southern Illinois Healthcare

Country: United States

Location : Zeigler, Illinois

Post: Thu, 14 Oct 2021 06:33:29 GMT

Expires: Sat, 13 Nov 2021 23:59:59 GMT

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—————————— Job Description ——————————

Responsible for protecting the rights and welfare of research subjects while performing biomedical and social-behavioral research in accordance with Good Clinical Practice, all federal regulatory bodies, and research protocols. The Clinical Trial Research Specialist is responsible for the facilitation and coordination of daily clinical trial activities and plays a critical role in the conduct of the study. The specialist works collaboratively with the entire clinical research team, Principal Investigators, patients, sponsors, and monitors. Responsibilities Recruits and verifies eligibility of study subjects in compliance with the principles of the Belmont Report, Good Clinical Practice, and federal regulations of OHRP and FDAReviews and obtains informed consent and documents processSchedules and conducts study visits with subjectsConducts follow-up phone calls with subjectsScores test resultsCollects survey data and review medical recordsConsults with nurses and physicians to determine subject eligibility according to protocol requirementsFacilitates communication with and education of investigators, key personnel and subjects to maintain project study flowMaintains detailed study records. Performs scientific literature searches in support of researchCompletes research documents in compliance with current local, state, and federal regulatory guidelines, requirements, laws and research protocolsParticipates in outreach to promote clinical research at SIH, including but not limited to outreach to physicians, staff, patients, or communityIdentifies, records, reports and follows Adverse Events (AE) and Serious Adverse Events (SAE). Collaborates with investigator to address AE and SAE resolutionIdentifies and reports protocol deviations, including corrective action plansMaintains test article (drug or device) and research supply accountability per protocol and SOPOccasional overnight travel to attend study training meetings, annual SOCRA or PRIM&R meetings and study audits as necessary (10%) Qualifications Bachelors degree in life sciences, health related, or administration program, public health, health sciences Or the equivalent combination of education and experience.Must complete CITI Human Subjects Research Training, before interacting with any participants and must complete continuing education annually or as certification demands.Clinical Research Professional certification within two years of hire.Technical Experience: 2 years practical experience in a related healthcare position (patient facing such as Certified Medical Assistant, compliance, etc.), or equivalent combination of education and experience. #PIQresearch PandoLogic.Category: Science, Keywords: Clinical Research Associate (CRA)

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