Clinical Research Associate

2 days ago

Somers Point, New Jersey, United States Medix™ Full time
Clinical Research Coordinator Job Description

At Medix®, we are seeking a highly skilled Clinical Research Coordinator to join our team. The successful candidate will be responsible for overseeing and coordinating the daily activities of clinical research studies.

Key Responsibilities:

  • Organize all aspects of assigned clinical trials, ensuring timely completion and compliance with protocol guidelines.
  • Participate in investigator meetings, site initiation meetings, and other relevant events as needed.
  • Collaborate with the internal recruitment department to ensure participant screening and enrollment, adhering to protocol and regulatory requirements.
  • Conduct informed consent processes and conduct study-related visits, maintaining accurate records and documentation.
  • Monitor subjects per protocol requirements, assessing and reporting adverse events as necessary.
  • Maintain required records of study activity, including source documentation, case report forms, and data management system entries.
  • Dispense test articles, calculate dosages, and provide instructions to participants.
  • Complete case report forms, resolve queries, and report protocol deviations to the PI, sponsor, and IRB as required.
  • Obtain, process, and ship study-related specimens, ensuring timely and accurate delivery.
  • Provide assistance to fellow study coordinators, promoting a collaborative team environment.
  • Manage quality assurance activities for assigned protocols, adhering to site SOPs and ensuring study quality and subject confidentiality.

Requirements:

  • Bachelor's Degree required; MS, LPN, RN, or other medical license or certification preferred.
  • Excellent leadership, organizational, computer, and communication skills.
  • Ability to multi-task, prioritize, and work effectively in a team environment.
  • Ability to maintain confidentiality and communicate effectively in a multi-office setting.
  • Efficient operation of job-related office equipment, including telephone, computer, calculator, fax, copier, and study-specific equipment.

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