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Clinical Trial Specialist

Company: Southern Illinois Healthcare
Location: Vergennes
Posted on: November 23, 2021

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 Role Specific 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 FDA
  • Reviews and obtains informed consent and documents process
  • Schedules and conducts study visits with subjects
  • Conducts follow-up phone calls with subjects
  • Scores test results
  • Collects survey data and review medical records
  • Consults with nurses and physicians to determine subject eligibility according to protocol requirements
  • Facilitates communication with and education of investigators, key personnel and subjects to maintain project study flow
  • Maintains detailed study records. Performs scientific literature searches in support of research
  • Completes research documents in compliance with current local, state, and federal regulatory guidelines, requirements, laws and research protocols
  • Participates in outreach to promote clinical research at SIH, including but not limited to outreach to physicians, staff, patients, or community
  • Identifies, records, reports and follows Adverse Events (AE) and Serious Adverse Events (SAE). Collaborates with investigator to address AE and SAE resolution
  • Identifies and reports protocol deviations, including corrective action plans
  • Maintains test article (drug or device) and research supply accountability per protocol and SOP
  • Occasional overnight travel to attend study training meetings, annual SOCRA or PRIM&R meetings and study audits as necessary (10%) Qualifications Education
    Bachelors degree in life sciences, health related, or administration program, public health, health sciences Or the equivalent combination of education and experience. Licenses and CertificationMust 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. Experience and Skills
    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 .
    Computer Experience: Working knowledge of Microsoft Office applications, electronic health systems, or have a willingness to learn and demonstrate proficiency
    Detail-oriented and meticulous in all aspects of work.
    Strong follow-through skills and ability to identify and solve problems; demonstrated initiative is imperative.
    Must have professional demeanor and strong communication skills with the public as well as physicians/researchers.
    Ability to work well independently as well as in a team environment.
    A self-starter with the ability to be flexible, organized, detail-oriented, and tenacious in follow-through.
    Possess the ability to work well under pressure, multi-task and manage deadlines.
    Strong interpersonal and customer service skills are critical.
    Ability to travel to physicians from Corporate location for screenings and follow-up activities with patients. #PIQresearch PandoLogic. Keywords: Clinical Research Associate (CRA), Location: Vergennes, IL - 62994

Keywords: Southern Illinois Healthcare, Evansville , Clinical Trial Specialist, Healthcare , Vergennes, Indiana

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