Clinical Research Coordinator

Flourish ResearchBirmingham, AL
$25 - $30Onsite

About The Position

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Flourish Research's Birmingham site is growing, and we are looking for a CRC to join the team. Our Birmingham research site conducts trials across various therapeutic areas, including vaccines, internal medicine, women's health, pediatrics, neurology, and more. The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.

Requirements

  • Bachelor's degree or commensurate clinical research work experience
  • A 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

  • Phlebotomy and EKG experience is nice to have, but not required
  • Preferably 1+ year of experience as a Clinical Research Coordinator
  • Familiar with e-source reporting via an electronic platform

Responsibilities

  • Execute protocol-specified patient visits and procedures, which may include, but not limited to, phlebotomy, IVs, injections, vital signs, ECG/EKG, etc.
  • Document assessments and study data per regs/GCP; maintain complete source; accurately complete CRFs/eCRFs.
  • Obtain informed consent per federal regs, GCP, and IRB requirements.
  • Ethically recruit qualified subjects to meet enrollment timelines.
  • Complete required/ongoing training; attend investigator meetings/courses; stay current with changing regulations and Flourish policies.
  • Schedule and conduct visits per protocol timelines.
  • Protect confidentiality per HIPAA and all confidentiality agreements.
  • Report AEs promptly; report SAEs to sponsor within 24 hours and notify PI/Sub-I/supervisor.
  • Account for and ensure availability of trial materials (study drug, labs, CRFs, supplies).
  • Maintain and document communication with Leads, Managers, PIs/Sub-Is, and 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.
  • 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
  • referral program
  • employee assistance program
  • life insurance
  • disability insurance
  • 15 days of PTO + 8 paid holidays and 2 floating holidays.
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