Prime Healthcare Services - Newark, NJ

posted 6 months ago

Full-time - Entry Level
Newark, NJ
251-500 employees
Ambulatory Health Care Services

About the position

Join an award-winning team of dedicated professionals committed to our core values of quality, compassion, and community at Saint Michael's Medical Center, a member of Prime Healthcare. This position as a Clinical Research Associate involves facilitating all implementation phases of new studies and coordinating ongoing clinical trials. You will work under the direction and supervision of the Director of Research, overseeing all clinical trial activities and assisting the Principal Investigator (PI) in recruiting patients for clinical studies. Your role will be crucial in ensuring compliance with regulatory standards and maintaining the integrity of the research process. As a Clinical Research Associate, you will collaborate closely with the Principal Investigator, department members, study sponsors, and monitors to support the administration of compliance, financial, personnel, and other related aspects of all ongoing clinical studies. This position requires a strong understanding of clinical trials, including knowledge of ICH/GCP, FDA regulations, and HIPAA compliance. You will be responsible for arranging and overseeing all clinical trial activities, ensuring that studies are conducted in accordance with established protocols and regulatory requirements. Saint Michael's Medical Center is a 358-bed regional tertiary-care, teaching, and research center located in Newark, NJ. The hospital is known for its innovative cardiac treatments and procedures, being the first in New Jersey to perform open-heart surgery and develop a cardiac catheterization program. By joining our team, you will be part of a community dedicated to making a difference in the lives of patients and their families.

Responsibilities

  • Facilitate all implementation phases of new studies.
  • Coordinate ongoing clinical trials and maintain open and closed studies.
  • Arrange and oversee all clinical trial activities.
  • Assist the Principal Investigator in recruiting patients for clinical studies.
  • Support and provide guidance on compliance, financial, personnel, and other related aspects of ongoing clinical studies.

Requirements

  • Minimum Bachelor's degree in Health Related Sciences or equivalent.
  • Clinical Trials HIPAA certification.
  • Knowledge of ICH/GCP, FDA, and IATA Guidelines.
  • Prior Electronic Data Capture (EDC) experience.
  • Knowledge of ICH/GCP Guidelines.
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