Clinical Research Coordinator

3 weeks ago

orlando, United States Elixia Full time

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.


Responsibilities: The Clinical Research Coordinator:

  • Performs study subject visits by, among other things;
  • Screening and recruiting subjects;
  • Dosing and administering study drugs and/or implementing study methodologies;
  • Accounting for study drugs;
  • Communicating with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators;
  • Collecting, labeling, storing, and shipping specimens collected from subjects in connection with a clinical research trial;
  • Entering patient and research data in systems designated by the Company; and
  • Maintaining patient charts and resolving research queries.
  • Follows Good Clinical Practice
  • Works cooperatively with others
  • Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site requirements and policies;
  • Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms;
  • Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed;
  • Assesses eligibility of potential subjectsthrough methods such as screeninginterviews, reviews of medical records,and discussions with physicians and other healthcare professionals;
  • Oversees subject enrollment to ensure that informed consentis properly obtainedand documented;
  • Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies;
  • Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups;
  • Creates source documents as assigned, such as regarding protocols, memos, patient participation;
  • Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports;
  • Reviews proposed study protocols to evaluate factorssuch as sample collection processes, data management plans,and potential subjectrisks;
  • Instructs research staff in scientific and procedural aspectsof studies includingstandards of care, informed consentprocedures, or documentation procedures;
  • Collaborateswith Investigators and Company Management to prepare presentations or reports of clinical studyprocedures, results, and conclusions;
  • Communicateswith laboratories or investigators regarding laboratory findings;
  • Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research;
  • Orders drugs or devices necessary for study completion;
  • Documents 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; and
  • Performs other duties as assigned, including duties routinely performed by the Company’s Research Assistants.


Requirements:

  • Knowledge of medical terminology
  • Understanding the principles of administration


Education:

  • High School Diploma
  • Or a degree in nursing or health related field
  • And 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


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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