CRA II, Home based UK

As a CRA working within the clinical operations team you will be at the forefront of clinical trials practice. You will be involved in Implementing and monitoring trials, ensuring that sponsor and investigator obligations are met and overseeing compliance with regulatory requirements. You will be working on a wide spectrum of projects in phase I-IV research at both GP practices and hospitals and across a range of therapeutic areas.

 

Responsibilities:

• Perform feasibility, pre-study site visits, study start-up, clinical trial initiation, monitoring and close out activities in accordance with regulations and SOP’s.

• Provide regular and accurate clinical status updates to the clinical team members and project management

• Perform investigator site file reconciliation and request any new or updated site related essential documents

• Preparation and coordination of investigator meetings and attends when required

• Develop monitoring plan, CRF’s and other study-related documents

 

Requirements

• Undergraduate degree (or equivalent) in a life sciences or clinical field combined with some onsite monitoring experience within a Pharmaceutical company or CRO.

• An understanding and knowledge of ICH and local regulatory authority regulations is essential as is the ability to work confidently with computerized information systems.

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