Clinical Trial Registries Associate

Clinical Trial Registries Associate
Company:

Software Guidance & Assistance


Clinical Trial Registries Associate

Details of the offer

Location: Irvine, CA
Bill : $100.00 HR

Responsibilities

Provide support in quality oversight of the Registry health for studies within and across programs

Contribute to Registry submission activities

Provide guidance in global Registry requirements

Provide support for Registry submission process improvement activities

Provide oversight on standard processes for registries and submission timelines to assigned study teams

Establish and Maintain Global Clinical Trial Registries

Collaborate with study teams to complete Initial Registrations, Standard Maintenance updates, and Results Submissions for applicable registries

Compile and maintain registry submission related documentation in internal systems on a timely basis

Assist senior team members to ensure harmonization of data across global registries as applicable

Assist senior team members to investigate and facilitate resolution of queries originating from global registries

Provide guidance in the general requirements of global registries based on internal supporting documents

Maintain effective cross-functional relationships to maximize contribution to quality activities

Assist with new or revised Registry processes to be developed

Fulfilment of Obligations Outlined in SOPs and Other Controlled Documents

Qualifications

Bachelor's degree

3 years of regulatory affairs experience


Source: Dice


Area:

Requirements

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