The Senior Clinical Research Associate performs activities associated with the evaluation, initiation, monitoring and close out of clinical trials to ensure the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICHGCP guidelines and other applicable regulatory requirements.
- Coordinate allocated projects and project activities in accordance with guidelines and SOPs with minimal supervision.
- Coordinate the required activities of stakeholders in the clinical project management process including sponsor, site and monitors.
- Monitor all aspects of studies to ensure compliance with GCP, study protocol and regulatory requirements and prepare monitoring reports.
- Perform Study Initiation, On-study and Study Close-out activities.
- Verify subject records, review essential documents, perform investigational product accountability, meet with site personnel and ensure procedures are conducted per the protocol.
- Site management between monitoring visits, contact sites, ensure adequate enrolment and document collection as required.
- Develop and review study protocols and other study related documents.
- Prepare documents related to a clinical trial.
- Perform internal review of study documents.
- Prepare ethics submissions.
- Design and review of Case Report Forms.
- Assist in preparation of Clinical Study Reports.
- Bachelor’s level degree in life sciences, pharmacy, nursing or appropriate industry experience.
- Experience working as a Clinical Research Associate (CRA) and SCRA.
- Minimum 3-5 years’ experience in the pharmaceutical industry / Contract Research Organization (CRO) working in a GCP environment.
- Formal CRA and ICH GCP training.
- Highly developed computer skills especially MS Office Suite.
- Ability to understand technical, scientific and medical information.