Florida Digestive Health Specialists LLP·Manatee County, Florida
The coordinator is responsible for screening, enrolling, and monitoring study subjects while ensuring strict protocol and regulatory compliance. They manage study workloads, interact with sponsors and CROs, and handle clinical procedures and data entry.
We are looking for a dedicated Clinical Research Coordinator II with integrity and a passion for advancing medicine through research.
This position will work out of our Largo, FL location.
The Clinical Research Coordinator II’s primary responsibilities are to screen, enroll and follow study subjects ensuring protocol and regulatory compliance and close monitoring while subjects are in study. Due to enhanced experience at FRI the Clinical Research Coordinator II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction, while conveying a positive image of FRI to community, sponsors, CRO’s and study participants and family members.
Inspire hope. Build your legacy. Founded in 2011, Florida Digestive Health Specialists (FDHS) is the state's largest single-specialty, physician-owned gastroenterology practice. FDHS provides unparalleled, compassionate gastroenterology care. With a mission to provide the highest quality digestive health services while fostering advanced research to improve patient outcomes, FDHS offers comprehensive care across 30 locations in Florida. The team includes many “Top Doctors” recognized by Castle Connolly for their clinical excellence and dedication to the communities they serve. This is a great organization to be a part of, so come join the team!
Duties: include but are not limited to:
Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
Contact scheduled Screening patients 72 hours prior to Screening appointment to verify pre-screened information has not changed
Obtain informed consent per FRI SOP and document process. When revised ICF is received and discussed with patients during the trial adequate documentation required
Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol and lab manual
Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
Review laboratory results, ECGs, and other test results (e.g., biopsy results) for completeness and alert values, ensure investigator review in a timely fashion
Recognize adverse events (AES) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and site regulatory coordinator. Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
Schedule patients within visit windows (including any outside procedures-MRI, biopsy, etc.), notify personnel as needed for procedures, and integrate visits with existing schedule to maximize efficient workflow and patient turnaround
Dispense study medication per protocol and or IVRS system. Educate patient on proper administration and importance of compliance
Monitor patient progress on study medication
Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
Accurately record study medication inventory, medication, dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmations are conducted in a timely fashion
Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed
Record protocol exemptions and deviations as appropriate with sponsor - Complete Memo to File for patients’ charts and regulatory filing if necessary
Ensure all sponsor correspondence (emails, telephone conversations) are printed and given to appropriate personnel for regulatory filing
Maintain copies of patient-specific correspondence in source charts
Assist regulatory personnel with completion of continuing/final review reports
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all- inclusive.
When you join FDHS, you become part of a premier team striving to deliver unparalleled, personalized care while treating patients like family. And at FDHS, our patients are at the heart of everything we do. Join our team at FDHS and make a difference in the lives of our patients and employees alike!
Requires three years of clinical research and coordinator experience, including specific competency or tenure at FRI. Preferred qualifications include an RN or LPN license and a CCRC professional certification.
Market context
In Florida, administration roles in healthcare often draw steady interest because employers want candidates who can keep patient flow, records, and front-office tasks organized. These positions are competitive when applicants bring clinical-setting experience, especially a medical background such as Medical Assistant work, along with strong communication and scheduling skills. Review the AI-summarized requirements and benefits on this platform to save time, and confirm your experience matches the clinical setting and diploma requirement before applying.
