Clinical Research Coordinator 227013

2 weeks ago

Montclair, United States Medix™ Full time

We are looking to add a CRC to our growing team- if you enjoy a collaborative environment and are looking for a company with a ton of room for growth- join our team We offer a competitive salary and great benefits


Qualified candidates will have at a minimum 3-4 years of experience working in therapeutic clinical trials.


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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