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 on study. Due to enhanced experience the CRC II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction, while conveying a positive image of Meridien Research to community, sponsors, CROs and study participants and family members.

We have positions available in; Decatur-GA, Lakeland-FL, Jacksonville-FL, Deland-FL, and Maitland-FL. PRN and full-time opportunities available. 

Essential Functions & Responsibilities:

• Review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies, etc.
• Participate in Investigator’s meeting and/or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives.
• Determine facility, equipment and outsource vendor availability.
• Integrate new trial load with existing trial load, delegate tasks as necessary, and prioritize activities regarding protocol timelines.
• Maintain organized files for blank source documents, patient charts, CRFs, and supplies.
• 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 Meridien team in an ongoing fashion.
• 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., mammogram) 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.
• 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.

• BS in nursing, pharmacy or other related science or combination of equivalent education preferred.
• RN or LPN preferred.
• Research Professional Certificate – CCRP or exam eligibility preferred.
• Four (4) years clinical research experience.
• Two (2) years Clinical Research Coordinator experience.
• 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.