Gastro Health · 2 months ago
Senior Clinical Research Coordinator
Pensacola, FL
Full-time
Onsite
Mid, Senior Level
3+ years expGastro Health, LLC is a leading medical group specializing in gastrointestinal disorders and clinical research. They are seeking a Senior Clinical Research Coordinator to oversee clinical trials, ensuring compliance with protocols and regulatory standards while working closely with study subjects and the Principal Investigator.
Health CareMedical
Responsibilities
Coordinate and participate in site preparation for Site Initiation Visits, interim Monitoring Visits, Investigator Meetings, and Close-Out visits
Ensure the safety and well-being of all study-related subjects throughout the course of their study participation
Work closely with the PI to ensure compliance with protocols, and successfully conduct all assigned study-related activities in accordance with FDA and ICH GCP guidelines
Ensure Standard Operating Procedures are enforced and followed with strict adherence to company policy
Assure IRB approvals are obtained prior to initiating any study-related activities
Recruit and track subjects with expectations for target enrollment goals
Current proficiency with conducting phlebotomy
Consent subjects in accordance with FDA, GCP and protocol guidelines
Ensure adequate understanding of inclusion and exclusion criteria for each protocol
Accurately record and communicate all adverse events (AEs) to the PI and monitor in a timely manner
Record all concomitant medications and medical/surgical history accurately for each subject
Schedule all subject visits within study timelines identified within the protocols
Ensure subject safety and communicate safety data in a timely manner with the PI
Collect and accurately record study data in source documents and case report forms
Design and maintain organizational tools to conduct study activity accurately and in compliance with GCP, FDA and protocol guidelines
Complete all paperwork as required by sponsor and CRA in a timely manner
Qualification
Required
3-5 years of Clinical Research experience required
Self-starter capable of working independently
Ability to thrive in a fast-paced, high-pressure environment
Desire to train and develop skills
Exceptional written and oral communication skills
Skills in Phlebotomy/Venipuncture
Ability to provide shadow support to entry-level research personnel
Knowledge of Protocol Deviations, Serious Adverse Events, and Safety Reports
1-2 years of experience utilizing a CTMS, EDC, IWRS/IXRS, EHR (AllScripts)
Preferred
Bachelor's Degree, preferred
Availability to travel as required for training sessions
Prior knowledge of clinical trials, as well as ICH-GCP principles, preferred
BLS certification, preferred
Familiarity with medical terminology
Knowledge of how to operate/conduct an ECG/EKG Machine
Certification via SOCRA and/or ACRP
Facilitation of Close-Out, Site Initiation, and Monitoring visits as required/needed
Benefits
Health
Dental
Vision
Paid Time Off
Life insurance
401k
Profit Sharing Plan
Short & Long-term disability
HSA
FSA
Corporate Holidays
Company
Gastro Health
Gastro Health is a medical practice company that provides gastroenterology adult and pediatrics services.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$100MKey Investors
PenfundOMERS Private EquityAudax Private Equity
2021-07-01Private Equity· $10M
2021-07-01Debt Financing· $90M
2021-05-19Secondary Market
Leadership Team
Lawrence Freni
Chief Financial Officer
Alan Oliver
Chief Operating Officer
Recent News
2024-04-07
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