Senior CRA / CRA II

My client is looking for a CRA with at least 12 months'  monitoring experience to home-based. The role will be working outsourced with an excellent Pharma company.  No specific therapy area knowledge is required as you will receive full indication and SOP training.

 

Responsibilities:

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage on-going project expectations and issues.

• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Lead and/or line manager.

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form completion and submission, and data query generation and resolution.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.

• May provide assistance to more less experienced clinical staff.

 

Requirements:

• Undergraduate degree (or equivalent) in a life sciences or clinical field combined with at least 12 months 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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