Clinical Research Coordinator

Flourish Research•Walnut Creek, CA

6d•$24 - $33•Onsite

About The Position

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
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

Phlebotomy and EKG experience is nice to have, but not required
Preferably 1+ year of experience as a Clinical Research Coordinator

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.