Clinical Research Coordinator CRC

We are looking to add a CRC to our growing team-this is a long term contract role, work life balance, beneftis and a great team working environment.

Qualified candidates will have at least 1-2 years of experience working in therapeutic or medical device clinical trials and must be able to do Phlebotomy.

Responsibilities include:

• Maintaining thorough knowledge of study-specific inclusion/exclusion criteria
• Performing safety and efficacy assessments per protocol
• Vital signs, EKGs, and other assessments as assigned
• Accurate and timely completion of source documents recording participant's participation in the study
• Communicate closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines
• Assist investigators in the collection of information from participants regarding AEs, concomitant medications, and other changes throughout participation
• Responsible for timely data entry and query resolution
• Timely reporting of study events (SAEs, protocol deviations, etc.)
• Following subjects through study completion and creating a follow-up care plan with a physician, study subject, and primary care provider;
• Ensuring preparation for and facilitating of all study monitoring visits and following up promptly with monitor follow-up letters
• Prompt and professional communication with sponsors, representatives, and other study-related parties
• Maintaining professional and appropriate interactions with study subjects, caregivers, sponsors, and all other study-related personnel, and staff members
• Interacting with nursing/unit staff on a daily basis as applicable to ensure communication and accurate completion of source through daily chart review
• Keeping CTM informed of study status and any study-related issues
• Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials

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