Clinical Research Coordinator

Flourish Research•Walnut Creek, CA

5d•Onsite

About The Position

Flourish Research is seeking a motivated and talented Clinical Research Coordinator to assist Investigators in executing Phase I, II, III, and IV clinical research trials. This role requires adherence to Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols, while ensuring an impeccable patient experience. The position is full-time, Monday-Friday, 8:30 AM - 5 PM, with flexibility needed for patient schedules. The compensation is $24-$33 per hour. Flourish Research is committed to diversity and inclusion, striving for excellence in clinical trials and healthcare by ensuring everyone receives the best care regardless of their background. We offer a comprehensive benefits package, a supportive work environment, and growth opportunities.

Requirements

Bachelor's degree or commensurate clinical research work experience
Familiarity 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

Phlebotomy and EKG experience
Preferably 1+ year of experience as a Clinical Research Coordinator

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/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 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 SAEs to the sponsor within 24 hours, notifying the 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 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.