Clinical Research Coordinator II - Lakewood Ranch

Florida Digestive Health Specialists is one of the largest single-specialty, physician-owned GI practices in Florida, providing comprehensive gastroenterology services and advanced research. The Clinical Research Coordinator II will screen, enroll, and follow study subjects, ensuring compliance with protocols and regulations while managing a greater study workload and interacting with sponsors and clinical research organizations.

Responsibilities

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

Integrate new trial load with existing trial load and prioritize activities with regard to protocol timelines

Maintain organized files for blank source 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 FRI team in an ongoing fashion

Develop and maintain effective relationships with study participants and FRI personnel

Complete End of Study Packets for Patient Liaisons

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

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

Preferred

RN or LPN preferred

Research Professional Certificate- CCRC or exam eligibility preferred

RN

LPN

Research Professional Certificate

CCRC

Company

Gastroenterology network screening, diagnosing, and treating digestive disorders

Bradenton, Florida, USA

https://www.fdhs.com/

Founded in 2011

201-500 employees

Qualifications

Three years clinical research experience

Three years Clinical Research Coordinator experience

A minimum of one year as a FRI Clinical Research Coordinator I or completion of FRI CRC competency form

Good working knowledge of medical and research terminology

Enhanced working knowledge of federal regulations, good clinical practices (GCP)

Ability 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

Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and Excel

Excellent interpersonal skills, detailed-oriented and meticulous

Excellent professional writing and communication skills

Ability to work independently in a fast-paced environment with minimal supervision

RN or LPN preferred

Research Professional Certificate- CCRC or exam eligibility preferred

Required skills

Clinical Research Coordination, Clinical Practices (GCP), Federal Regulations Compliance, Medical and Research Terminology, Clinical Trials Database, Electronic Data Capture (EDC), Microsoft Word, Microsoft Excel, Blood Draws, Vital Signs Measurement, Electrocardiograms (ECGs), Informed Consent Process, Adverse Event Recognition and Reporting, Investigational Product Accountability, Patient Recruitment and Screening

Preferred skills

RN or LPN preferred, Florida Digestive Health Specialists is a healthcare., Bradenton, Florida, USA, https://www.fdhs.com, Growth Stage, Recent News, Business Wire, 2024-02-04, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

3+ years