Florida Digestive Health Specialists
Clinical Research Coordinator III - Largo
Florida Digestive Health Specialists, Bradenton, Florida, United States, 34205
Physical Work Location: Florida Center for Gastroenterology - 13777 Belcher Rd S. Ste 100; Largo, FL 33771
Description/Job Summary:
The primary responsibilities of Florida Research Institute (FRI)'s most experienced and highly qualified Clinical Research Coordinator III (CRC III) is to screen, enroll and follow study subjects for a significant number of FRI's most complex protocols and key Sponsors/CROs; all the while ensuring optimum enrollment rates, protocol and regulatory compliance and close monitoring while subjects are in study and constantly conveying a positive image of FRI to community, sponsors, CROs and study participants and family members.
The CRC III will continue to assist CRC I and II in continuing to hone their skills and improve the overall quality of their work product, while mentoring assigned new CRC I(s) and ensuring that their knowledge of clinical research is sufficient to address the continuing needs of their study load and to ensure that over time they can assume a greater role and responsibility within FRI.
Our Culture: Inspire hope. Build your legacy.
Discover a rewarding, fulfilling, well-balanced career at Florida Research Institute, a division of Florida Digestive Health Specialist, 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.
Essential Duties:
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 task Study Management
Integrate new trial load with existing trial load, delegate tasks as necessary, and prioritize activities with regard to protocol timelines Maintain organized files for blank source documents, patient charts, CRFs and supplies 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 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 Patient Coordination
Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment Obtain informed consent per FRI SOP and document process when revised ICF is discussed with patients during the course of the trial Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol 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., MRI and Biopsy reports) 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, 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 patients on proper administration and importance of compliance Monitor patients' progress on study medication 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 is 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) is 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 Other duties as assigned
Please note that the duties and responsibilities outlined in this job description are not exhaustive and may be subject to change at any time to meet the evolving needs of the company.
Qualifications
Excellent working knowledge of medical and research terminology Extensive working knowledge of federal regulations, good clinical practices (GCP) Ability and willingness to mentor and guide less experienced CRCs as they develop and gain experience Ability to communicate and work effectively with a diverse team of professionals Excellent organizational, prioritization and leadership skills and capabilities Education/Experience/Certification
Life Science Degree or combination of equivalent education preferred Six years Clinical Research experience Four years Clinical Research Coordinator experience Research Professional Certificate- CCRC or exam eligibility preferred
Description/Job Summary:
The primary responsibilities of Florida Research Institute (FRI)'s most experienced and highly qualified Clinical Research Coordinator III (CRC III) is to screen, enroll and follow study subjects for a significant number of FRI's most complex protocols and key Sponsors/CROs; all the while ensuring optimum enrollment rates, protocol and regulatory compliance and close monitoring while subjects are in study and constantly conveying a positive image of FRI to community, sponsors, CROs and study participants and family members.
The CRC III will continue to assist CRC I and II in continuing to hone their skills and improve the overall quality of their work product, while mentoring assigned new CRC I(s) and ensuring that their knowledge of clinical research is sufficient to address the continuing needs of their study load and to ensure that over time they can assume a greater role and responsibility within FRI.
Our Culture: Inspire hope. Build your legacy.
Discover a rewarding, fulfilling, well-balanced career at Florida Research Institute, a division of Florida Digestive Health Specialist, 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.
Essential Duties:
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 task Study Management
Integrate new trial load with existing trial load, delegate tasks as necessary, and prioritize activities with regard to protocol timelines Maintain organized files for blank source documents, patient charts, CRFs and supplies 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 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 Patient Coordination
Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment Obtain informed consent per FRI SOP and document process when revised ICF is discussed with patients during the course of the trial Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol 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., MRI and Biopsy reports) 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, 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 patients on proper administration and importance of compliance Monitor patients' progress on study medication 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 is 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) is 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 Other duties as assigned
Please note that the duties and responsibilities outlined in this job description are not exhaustive and may be subject to change at any time to meet the evolving needs of the company.
Qualifications
Excellent working knowledge of medical and research terminology Extensive working knowledge of federal regulations, good clinical practices (GCP) Ability and willingness to mentor and guide less experienced CRCs as they develop and gain experience Ability to communicate and work effectively with a diverse team of professionals Excellent organizational, prioritization and leadership skills and capabilities Education/Experience/Certification
Life Science Degree or combination of equivalent education preferred Six years Clinical Research experience Four years Clinical Research Coordinator experience Research Professional Certificate- CCRC or exam eligibility preferred