Clinical Research Coordinator

2 weeks ago

Orlando, United States Elixia Full time

Who are we?

Elixia is a trusted clinical site organization, providing industry-leading patient recruitment and clinical trials management and analysis for Cardiology/Nephrology, Behavioral Health, and Infectious Disease – not just for a single trial, but across your entire therapeutic pipeline.


We are seeking a dedicated Clinical Research Coordinator to join our team. The ideal candidate will play a vital role in managing clinical trials and ensuring compliance with FDA regulations and protocols.


Summary: 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


Responsibilities: The Clinical Research Coordinator

  • 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 subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals;
  • Oversees subject enrollment to ensure that informed consent is properly obtained and 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 factors such as sample collection processes, data management plans, and potential subject risks;
  • Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures;
  • Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions;
  • Communicates with 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.


Qualifications

  • Proficiency in FDA regulations governing clinical trials
  • Experience with statistical software for data analysis
  • Strong supervisory skills to lead research staff effectively
  • Ability to collect and manage research data accurately
  • Familiarity with documentation review processes in clinical research
  • Capability to perform phlebotomy procedures
  • Knowledge of medical terminology relevant to clinical trials management
  • Previous experience in a clinical research settings
  • Good Clinical Practice (GCP) Certification
  • IATA Certification


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.


Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Parental leave
  • Retirement plan
  • Vision insurance


Medical Specialty:

  • Infectious Disease
  • Nephrology


Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday
  • Weekends as needed


Language:

  • Spanish (Preferred)


License/Certification:

  • Good Clinical Practice Certificate (Required)
  • IATA Certification (Required)


Ability to Commute:

  • Orlando, FL 32806 (Required)


Ability to Relocate:

  • Orlando, FL 32806: Relocate before starting work (Required)


Work Location:

In person

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