Clinical Research Coordinator
Flourish Research
Summary
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 interaction.
Job description
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.
Qualifications
- Bachelor's degree preferred, but not required
- Must have oncology clinical research experience
- Minimum of two years of clinical research experience
- Clinical skills highly preferred: vital signs, EKG/ECG, phlebotomy, and injections
- Familiar with e-source reporting via an electronic platform
- 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
Requirements
- Must have oncology clinical research experience
- Minimum of two years of clinical research experience
- Familiar with e-source reporting via an electronic platform
- A clear understanding of ICH, FDA, and GCP regulations
- Impeccable organizational skills and attention to detail
- Excellent communication and interpersonal skills
- High-level critical thinking skills
- Working knowledge of medical terminology and lab collection/processing/storage procedures
- Proficiency with computers and Microsoft Office Suite
- Bachelor's degree preferred, but not required
- Clinical skills highly preferred: vital signs, EKG/ECG, phlebotomy, and injections
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Matching
- Tuition Reimbursement
- Parental Leave
- Referral Program
- Employee Assistance Program
- Life Insurance
- Disability Insurance
- Paid Time Off
- Paid Holidays
Company overview
Flourish Research is a leading multi-site clinical trial organization with a national footprint across the United States. Founded in 2021 and headquartered in Apex, North Carolina, the company operates as a fully integrated clinical trial organization that acquires and operates best-in-class research sites. With over 20 locations nationwide, Flourish Research specializes in three main therapeutic areas: Neuroscience (including Alzheimer's disease research), Infectious Diseases (with significant contributions to COVID-19 vaccine development), and Cardiovascular/Metabolic/Kidney disorders. The company provides comprehensive clinical trial services from Phase I to Phase IV studies, featuring early-phase inpatient units, AI-assisted patient recruitment, and site start-up support. Flourish Research is recognized for its commitment to patient diversity, high retention rates, and quality data delivery, having completed over 5,500 successful trials with 400,000 potential participants. The organization emphasizes physician-led research models and maintains strategic partnerships with pharmaceutical and biotech sponsors to accelerate the development of innovative treatments for unmet medical needs.