Clinical Res Coordinator II

Florida Digestive Health Specialists LLP • FL

95d

About The Position

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 community, sponsors, CRO’s and study participants and family members.

Requirements

• Four years clinical research experience.
• Two years Clinical Research Coordinator experience.
• A minimum of one year as a FRI Clinical Research Coordinator I or completion of FRI CRC competency form.

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.
• 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.
• 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.
• Integrate monitoring visits and study teleconferences into existing work schedule.
• 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.
• 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.
• 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 for completeness and alert values.
• Recognize adverse events (AES) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and site regulatory coordinator.
• Schedule patients within visit windows and integrate visits with existing schedule to maximize efficient workflow and patient turnaround.
• Dispense study medication per protocol and educate patient on proper administration and importance of compliance.
• Monitor patient progress on study medication.
• Record data legibly, in real time on source documents.
• Accurately record study medication inventory, medication, dispensation, and patient compliance.
• Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart.
• Accurately transcribe data to CRFs and resolve data management queries.
• Record protocol exemptions and deviations as appropriate with sponsor.
• Ensure all sponsor correspondence 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.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 251-500 employees