Job DescriptionIf you’re looking to progress and develop faster than is possible within a traditional large CRO and you want to work in a fast paced and exciting company with a full service role (start up to close out), then let’s have a confidential talk about the below opportunity. No strings attached!
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.