Research Assistant

Flourish Research•Gainesville, GA

16d•Onsite

About The Position

Flourish Research is seeking a motivated and talented Research Assistant to support our Gainesville site. This role is crucial in contributing to research that changes lives. We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. The Research Assistant will support CRCs and site staff with protocol-specified patient visits and procedures, document assessments and study data, obtain and document informed consent, support patient recruitment, maintain source documentation, report adverse events, manage study supplies, and maintain confidentiality. The role requires a strong understanding of ICH, FDA, and GCP regulations, excellent organizational and communication skills, and a high-level critical thinking ability. Proficiency with computers and Microsoft Office Suite is also necessary.

Requirements

Clinical research experience is required
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 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
Oncology clinical research experience is preferred
Clinical skills preferred: vital signs, EKG/ECG, phlebotomy, and injections

Responsibilities

Support CRCs and site staff with 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
Obtain and document informed consent following federal regulations and IRB guidelines
Support patient recruitment efforts and scheduling to meet enrollment goals
Maintain accurate source documentation and complete case report forms (CRFs)
Report adverse events to supervisors or investigators as needed
Help manage study supplies, lab kits, and other trial materials
Maintain confidentiality and follow all applicable compliance and ethical standards
Communicate effectively with research team members and document relevant study communications
Represent Flourish Research professionally in all interactions
Perform additional duties as assigned by management