Clinical Research Coordinator

Flourish ResearchMandeville, LA
Onsite

About The Position

Flourish Research is seeking a motivated and talented Clinical Research Coordinator to join our team at our Mandeville, Louisiana site. This role is crucial in supporting clinical trials across various therapeutic areas, including cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. We are committed to providing a safe, inclusive, and supportive work environment where employees can grow their careers while contributing to life-changing research. We offer a comprehensive benefits package and opportunities for professional development.

Requirements

  • Minimum of two years of clinical research experience.
  • Clinical skills preferred: vital signs, EKG/ECG, phlebotomy, and injections.
  • Familiarity with e-source reporting via an electronic platform.
  • Clear understanding of ICH, FDA, and GCP regulations.
  • Impeccable organizational skills and attention to detail.
  • Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources.
  • An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven.
  • High-level critical thinking skills.
  • Working knowledge of medical terminology and lab collection/processing/storage procedures.
  • Proficiency with computers and Microsoft Office Suite.

Nice To Haves

  • Bachelor's degree preferred.

Responsibilities

  • Execute protocol-specified patient visits and procedures, including phlebotomy, IVs, injections, vital signs, and ECG/EKG.
  • Document assessments and study data according to regulations and GCP, maintain complete source documentation, and accurately complete CRFs/eCRFs.
  • Obtain informed consent in compliance with federal regulations, GCP, and IRB requirements.
  • Ethically recruit qualified subjects to meet enrollment timelines.
  • Complete required and ongoing training, attend investigator meetings/courses, and stay current with changing regulations and Flourish policies.
  • Schedule and conduct visits according to protocol timelines.
  • Protect confidentiality in accordance with HIPAA and all confidentiality agreements.
  • Report AEs promptly and SAEs to the sponsor within 24 hours, notifying the PI/Sub-I/supervisor.
  • Account for and ensure the availability of trial materials such as study drug, labs, CRFs, and supplies.
  • Maintain and document communication with Leads, Managers, PIs/Sub-Is, and the study team per protocol and policy.
  • Perform duties safely, and in a time-/cost-effective manner compliant with Flourish policies.
  • Represent Flourish professionally in all interactions.
  • Perform additional duties as assigned by management.

Benefits

  • Health, dental, and vision insurance plans
  • 401(k) with a 100% employer match on the first 4% of employee contributions
  • Tuition reimbursement
  • Parental leave
  • Employee referral program
  • Employee assistance program
  • Life insurance
  • Disability insurance
  • Generous PTO plan covering vacation, sick, personal days
  • 8 paid holidays
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