Clinical Research Coordinator II

Flourish Research•Detroit, MI

4d•Onsite

About The Position

Flourish Research is seeking a motivated and talented Clinical Research Coordinator II to support their Detroit, MI site. This role involves executing protocol-specified patient visits and procedures, documenting assessments and study data, obtaining informed consent, recruiting subjects, completing required training, scheduling visits, protecting confidentiality, reporting adverse events, managing trial materials, and communicating with the study team. The position requires performing duties safely, efficiently, and in compliance with Flourish policies, while representing the company professionally.

Requirements

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

Nice To Haves

Bachelor's degree preferred, but not required

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.