Clinical Research Coordinator 1

IRE•Nashville, TN
•Onsite

About The Position

ICON’s Accellacare team is seeking a Clinical Research Coordinator 1 to help ensure volunteer safety, support the mission of Accellacare, and meet study priorities. The role recruits suitable clinical trial participants, promotes the site’s services to participants and sponsor representatives, and coordinates study activities in accordance with study protocols. The position is 100% onsite at Accellacare in Hermitage, Tennessee, with hours Monday through Friday, 8:00 a.m. to 5:00 p.m.; weekends and holidays are not required. The coordinator performs protocol-required clinical procedures, supports study drug preparation and administration, monitors for complications, maintains study and medication records, documents laboratory data and adverse reactions, and promptly reports unexpected or serious events when indicated. The role also supports recruitment, sponsor and monitor interactions, data entry, audits, clinical supplies and rescue drugs, temperature monitoring, laboratory procedures, equipment calibration, staff training, and site safety responsibilities. The position serves as the site’s OSHA Representative, including maintaining employee immunization records and administering vaccines to staff when necessary.

Requirements

  • At least 1 year of work experience in a clinical research or pharmaceutical environment.
  • Strong attention to detail.
  • Motivation to pursue a career in clinical research.
  • Excellent time management and planning skills, with an organized approach to work.
  • Bachelor’s degree in life sciences or another related field.
  • Legal right to work in the country where the role is based.

Responsibilities

  • Perform clinical and technical procedures required by study protocols, such as venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holter monitoring, pulmonary function testing, allergy testing, pregnancy testing, strep screening, and injections.
  • Attend investigator meetings, site initiation visits, and coordinator meetings to receive protocol and clinical-procedure training.
  • Obtain and maintain knowledge of study drugs, particularly injectable and intravenous infusion medications.
  • Monitor for potential complications associated with study drug administration, especially injections and IV infusions.
  • Maintain accurate drug dispensing logs, including lot number, drug or placebo status, and information about medication mixers or preparers.
  • Document laboratory data and adverse reactions, and promptly notify investigators, sponsors, and the Institutional Review Board of unexpected or serious events when indicated.
  • Assist other staff according to the research organization’s needs, priorities, and the coordinator’s time and abilities.
  • Recruit suitable clinical trial participants and promote the site’s services, with dedicated weekly time for recruitment efforts.
  • Promote the site with monitors and internal contacts to support future trials.
  • Respond promptly to queries, enter data in a timely manner, and work with monitors during onsite visits.
  • Prepare study documentation for sponsor or FDA audits and assist the auditor throughout the audit.
  • Order clinical supplies and protocol-specific rescue drugs; store and monitor rescue drugs; and conduct and document scheduled assessments of the code/crash cart and AED.
  • Monitor refrigerators, freezers, and investigational product storage temperatures to support product safety and stability.
  • Maintain knowledge of temperature-monitoring devices and procedures for laboratory specimens and investigational products, and explain temperature-monitoring practices to staff and sponsors.
  • Maintain certification for packaging and shipping specimens on dry ice and keep laboratory-procedure knowledge current to support workflow.
  • Serve as the site OSHA Representative, including maintaining employee immunization records, obtaining vaccines when necessary, and administering vaccines to staff.
  • Perform equipment calibration when needed if it is not handled by the lab coordinator or an outside service, and maintain calibration records.
  • Support training and development of clinical skills for site staff as needed.

Benefits

  • Competitive base salary and performance-related incentives.
  • Medical, dental, and vision coverage, where applicable.
  • Retirement and pension plans.
  • Life assurance and disability coverage.
  • Employee assistance programmes and wellbeing resources.
  • Learning and development opportunities through structured training and career pathways.
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