Clinical Research Coordinator

4 days ago

Hialeah, Florida, United States Evolution Research Group Full time
About the Role

We are seeking a highly skilled and detail-oriented Clinical Research Coordinator to join our team at Evolution Research Group. As a Clinical Research Coordinator, you will play a critical role in the success of our clinical trials by ensuring the smooth execution of study procedures and maintaining accurate records.

Key Responsibilities
  • Clinical Responsibilities:
    • Assist in the administration of informed consent and ensure that participants understand the study procedures and risks.
    • Assist with the administration of study drugs and ensure that participants receive the correct dosage.
    • Capture and report adverse events, including serious adverse events, in a timely and accurate manner.
    • Notify the Clinical Research Coordinator and management staff of abnormal results, adverse events, or unusual incidents.
    • Ensure minimal discomfort for study participants while performing all duties.
    • Check and ensure that participants are ready for study procedures in a timely manner.
    • Check and ensure that the procedure area is set up according to protocol requirements.
    • Perform routine blood drawing procedures, including venipuncture techniques using standard equipment.
    • Confer with patients to obtain information for laboratory records, explain procedures, and elicit cooperation.
    • Choose appropriate vials and containers necessary for specimen collection, depending on the tests ordered.
    • Maintain skills in the use of EKG machines and taking accurate vital signs.
    • Assist staff and medical staff with study participant care as requested, including lifting patients, cardiopulmonary resuscitation, bandaging, and other life-saving measures as directed.
    • Participate in all study initiation meetings for assigned studies.
    • Provide top-quality care and handle high levels of stress.
    • Clinical skills indicated by level of education, licensure, registration, and/or certification.
    • Perform study events and collect clinical data as directed by the principal investigator and protocol.
  • Administrative Responsibilities:
    • Monitor and ensure that study data is collected following the plan of care, guidelines, and identified group resources.
    • Participate in collaborative team efforts with other departments.
    • Check and ensure that procedure areas are properly stocked with study supplies and equipment.
    • Assist assigned Clinical Research Coordinator in reviewing study schedules to ensure that study procedures are properly prepared.
    • Anticipate, recognize, and resolve issues.
    • Recognize the need to seek assistance or inform senior management of specific issues.
    • Read and understand each protocol in which they are involved.
    • Follow established guidelines in the collection of clinical data and/or administration of clinical studies.
  • Educational Responsibilities:
    • Maintain current licensure, registration, and/or certification within educational background.
    • Maintain current BLS and/or ACLS certification.
    • Maintain necessary CEUs for licensure, registration, and/or certification.
    • Actively participate in ongoing Quality Assurance Program, HIPAA, and Compliance Programs.
    • Keep apprised of all new OSHA and GCP/ICH rules and regulations.
    • Attend all appropriate team meetings regarding study protocols.
    • Maintain skills in the use of EKG machines, Holter hook-up and monitoring, diabetic monitoring, and taking accurate vital signs.
    • Read and understand policy and procedures manuals, SOP manual, and employee handbook.
Requirements
  • Education and experience: Professional licensure, registration, and/or certification in a clinical or allied health field is preferred with a minimum of one year of clinical research experience.
  • BLS and/or ACLS, phlebotomy, and injections certifications preferred but not required.
  • Certified Clinical Research Coordinator (CCRC) preferred but not required.
  • Bilingual skills are preferred but not required.
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology.
  • Excellent communication skills (interpersonal, written, verbal).
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as RealTime and other Electronic Data Entry platforms).

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