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Clinical Research Associate (CRA)


Clinical Research Associate (CRA) runs and monitors clinical trials to determine safety and efficacy of drugs, medical devices and diagnostic products that are intended for human use. A CRA is typically involved in all stages of the clinical trial including initiating, monitoring and closing down the trial, and setting up of investigational site.

Responsibilities:

  • Develop and write trial protocols and other related documentation (that outline the purpose and methodology of a trial) and ensure they are in accordance with GCP regulatory requirements
  • Design the data collection forms, known as case report forms (CRFs)
  • Identify and assess the suitability of facilities to be used as the clinical trial site
  • Assist in site set-up and management activities, and train the site staff to trial-specific industry standards
  • Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis
  • Ensure compliance with the study protocol and provide regular updates to the Clinical Project Manager
  • Verify that data entered on the CRFs is consistent with patient clinical notes, commonly known as source data verification
  • Ensure timely revisions of Informed Consent Forms (ICFs), CRFs and other documentation for accuracy
  • Coordinate with the ethics committee to ensure the safety and wellbeing of all trial subjects
  • Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
  • Ensure all unused trial supplies are accounted for
  • Liaise with doctors/consultants or investigators on conducting the trial

Eligibility: A minimum of Bachelor’s degree in life sciences, microbiology or related fields, or a healthcare degree in pharmacy, nursing (RN or BSN), MD, physiotherapy or dentistry, or equivalent qualification/work experience.
Current Openings

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