Florida Digestive Health Specialists
Clinical Res Coordinator II
Florida Digestive Health Specialists, Florida, New York, United States
Join to apply for the
Clinical Res Coordinator II
role at
Florida Digestive Health Specialists
Florida Digestive Health Specialists provided pay range This range is provided by Florida Digestive Health Specialists. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $61,000.00/yr - $68,000.00/yr
Job Summary:
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 CRC II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction, while conveying a positive image of FRI to the community, sponsors, CROs and study participants and family members.
Our Culture: Inspire hope. Build your legacy.
Discover a rewarding, fulfilling, well-balanced career at Florida Research Institute, a division of Florida Digestive Health Specialists, LLP. With providers and locations across Florida, FDHS is one of the largest single-specialty, physician-owned GI practices in the state. FDHS was established in 2011 to provide comprehensive, high-quality gastroenterology services and foster advanced research for digestive health problems. With a growing team of nationally acclaimed care centers, providers, and staff, we continue to expand our reach to communities that need our care.
Study Preparation
Review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies, etc.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff.
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from database.
Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies.
Participate in Investigator’s meeting and/or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives.
Create (or review sponsor-provided) protocol-specific source documents.
Determine facility, equipment and outsource vendor availability.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).
Ensure education of staff and/or sub-investigators is completed for required tasks.
Study Management
Integrate new trial load with existing trial load and prioritize activities with regard to protocol timelines.
Maintain organized files for blank sourced documents, patient charts, CRFs and supplies.
EDC entry of required visits within 72 hours of visit elements being completed.
Investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records.
Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings.
Ensure trial activities are discussed in advance with covering personnel in case of vacation or sick leave.
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Communicate sponsor updates, patient-specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of the FRI team in an ongoing fashion.
Develop and maintain effective relationships with study participants and FRI personnel.
Interact in a positive, professional manner with patients, sponsor representatives, offices/investigators, and FRI personnel.
Communicate clearly verbally and in writing.
Accept accountability for actions and function independently.
Pre‑screen 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 symptom treatment is initiated as prescribed or 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.
Documentation
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.
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.
Knowledge, Skills, and Abilities
Good working knowledge of medical and research terminology.
Enhanced working knowledge of federal regulations, good clinical practices (GCP).
Ability to mentor and guide experienced CRCs as they develop and gain experience.
Ability to communicate and work effectively with a diverse team of professionals.
Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and Excel.
Excellent interpersonal skills, detail‑oriented and meticulous.
Ability to work independently in a fast‑paced environment with minimal supervision.
Experience
Two years clinical research experience.
A minimum of one year as FRI Clinical Research Coordinator I or completion of FRI CRC competency form.
License/Certification
RN or LPN preferred.
Research Professional Certificate – CCRC or exam eligibility preferred.
-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!
Seniority level Entry level
Employment type Full‑time
Job function Health Care Provider
Industries Hospitals and Health Care
#J-18808-Ljbffr
Clinical Res Coordinator II
role at
Florida Digestive Health Specialists
Florida Digestive Health Specialists provided pay range This range is provided by Florida Digestive Health Specialists. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $61,000.00/yr - $68,000.00/yr
Job Summary:
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 CRC II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction, while conveying a positive image of FRI to the community, sponsors, CROs and study participants and family members.
Our Culture: Inspire hope. Build your legacy.
Discover a rewarding, fulfilling, well-balanced career at Florida Research Institute, a division of Florida Digestive Health Specialists, LLP. With providers and locations across Florida, FDHS is one of the largest single-specialty, physician-owned GI practices in the state. FDHS was established in 2011 to provide comprehensive, high-quality gastroenterology services and foster advanced research for digestive health problems. With a growing team of nationally acclaimed care centers, providers, and staff, we continue to expand our reach to communities that need our care.
Study Preparation
Review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies, etc.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff.
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from database.
Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies.
Participate in Investigator’s meeting and/or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives.
Create (or review sponsor-provided) protocol-specific source documents.
Determine facility, equipment and outsource vendor availability.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).
Ensure education of staff and/or sub-investigators is completed for required tasks.
Study Management
Integrate new trial load with existing trial load and prioritize activities with regard to protocol timelines.
Maintain organized files for blank sourced documents, patient charts, CRFs and supplies.
EDC entry of required visits within 72 hours of visit elements being completed.
Investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records.
Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings.
Ensure trial activities are discussed in advance with covering personnel in case of vacation or sick leave.
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Communicate sponsor updates, patient-specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of the FRI team in an ongoing fashion.
Develop and maintain effective relationships with study participants and FRI personnel.
Interact in a positive, professional manner with patients, sponsor representatives, offices/investigators, and FRI personnel.
Communicate clearly verbally and in writing.
Accept accountability for actions and function independently.
Pre‑screen 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 symptom treatment is initiated as prescribed or 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.
Documentation
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.
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.
Knowledge, Skills, and Abilities
Good working knowledge of medical and research terminology.
Enhanced working knowledge of federal regulations, good clinical practices (GCP).
Ability to mentor and guide experienced CRCs as they develop and gain experience.
Ability to communicate and work effectively with a diverse team of professionals.
Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and Excel.
Excellent interpersonal skills, detail‑oriented and meticulous.
Ability to work independently in a fast‑paced environment with minimal supervision.
Experience
Two years clinical research experience.
A minimum of one year as FRI Clinical Research Coordinator I or completion of FRI CRC competency form.
License/Certification
RN or LPN preferred.
Research Professional Certificate – CCRC or exam eligibility preferred.
-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!
Seniority level Entry level
Employment type Full‑time
Job function Health Care Provider
Industries Hospitals and Health Care
#J-18808-Ljbffr