Clinical Research Coordinator

6 days ago

Saint Peters, Missouri, United States ELIXIA LLC Full time
Job Description

Summary: The Clinical Research Coordinator will plan, direct, or coordinate clinical research projects, and will evaluate, analyze clinical data and exercise discretion and independent judgment with matters of significance.

Key Responsibilities:

  • Perform study subject visits by screening and recruiting subjects, dosing and administering study drugs, and accounting for study drugs.
  • Communicate with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators.
  • Collect, label, store, and ship specimens collected from subjects in connection with a clinical research trial.
  • Enter patient and research data in systems designated by the Company.
  • Maintain patient charts and resolve research queries.
  • Follow Good Clinical Practice and work cooperatively with others.
  • Monitor study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site requirements and policies.
  • Track enrollment status of subjects and document dropout information.
  • Assess eligibility of potential subjects through screening interviews, reviews of medical records, and discussions with physicians and other health care professionals.
  • Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
  • Record adverse events and side effect data and confer with Investigators regarding the reporting of events to oversight agencies.
  • Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups.
  • Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
  • Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
  • Instruct research staff in scientific and procedural aspects of studies, including standards of care, informed consent procedures, or documentation procedures.
  • Collaborate with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions.
  • Communicate with laboratories or investigators regarding laboratory findings.
  • Review scientific literature, participate in continuing education activities, and/or attend conferences and seminars to maintain knowledge of clinical research.
  • Order drugs or devices necessary for study completion.
  • Document findings and events in the Company's research CTMS platform and in other binders and platforms as directed.
  • Occasional travel to Company sites, Investigator meetings, and/or Company meetings.

Requirements:

  • Knowledge of medical terminology and understanding of the principles of administration and management.

Education:

  • High School Diploma or a degree in nursing or a health-related field.
  • 1-5 years of on-the-job training as a clinical research assistant or research study coordinator.

Continuing Education:

  • IATA (dangerous goods handling)
  • GCP (good clinical practice)
  • BLS/Phlebotomist course, if required for the position
  • CPR course, as arranged from time to time by the Company on-site
  • Stericycle Trainings, first week of your start date
  • Maintain evidence of completion of all continuing education

Physical Requirements and/or Environmental Factors:

  • Prolonged periods of sitting at a desk and working on a computer.
  • Prolonged periods of standing and walking around the office.
  • Must be able to lift 20 pounds at times.
  • Travel to sponsor required meetings as needed.
  • Exposure to human bodily fluids.
  • Occasional night and weekend work schedules.
  • Overtime may be required at times.
  • Work is normally performed in a typical interior clinical/office environment.

At Will Employment: THE COMPANY IS AN AT-WILL EMPLOYER. THIS MEANS THAT EITHER YOU OR THE COMPANY MAY TERMINATE THE EMPLOYMENT RELATIONSHIP AT ANY TIME, FOR ANY REASON, WITH OR WITHOUT CAUSE.

Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

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