Clinical Research Coordinator II

Florida Digestive Health Specialists LLP• LAKEWOOD RANCH, FL, US, FL

11d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

RN or LPN preferred
Research Professional Certificate- CCRC or exam eligibility preferred

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 the 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.