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.
- 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.