Clinical Research Coordinator

Flourish Research•Leesburg, FL

16d•Onsite

About The Position

Flourish Research is seeking a motivated and talented Clinical Research Coordinator to support our Leesburg, FL site. This role is crucial in conducting clinical trials that contribute to life-changing research. We are a progressive and diversified clinical trial organization with strong capabilities across various therapeutic areas. At Flourish Research, we are committed to excellence, diversity, and inclusion, ensuring everyone receives the best care. We offer a supportive and collaborative work environment with endless growth opportunities and a comprehensive benefits package.

Requirements

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

Nice To Haves

Bachelor's degree preferred, but not required

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 per protocol timelines.
Protect confidentiality in accordance with HIPAA and all confidentiality agreements.
Report AEs promptly and report SAEs to the sponsor within 24 hours, notifying the PI/Sub-I/supervisor.
Account for and ensure the availability of trial materials (study drug, labs, CRFs, 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.