Job Description

Target PR Range: 33-43/hr
*Depending on experience

Summary:

The main functions of an Associate Specialist, Clinical Research is to perform general study management support activities and assist in the processing of study/site/vendor payments in collaboration with Clinical Execution project teams.

Key Responsibilities:

• Assist in the review, maintenance of study & site documents, supporting the management of document files and associated quality review activities
• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
• Conduct in-house reviews of associated documentation and may support internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations (as needed)
• Assess current processes, identify opportunities and propose solutions to improve process efficiencies, tracking and reporting
• Assist and support the timely review, tracking, and processing of study, site & vendor payments (ie. processing of invoices)
• Assist in the reconciliation and tracking of payment queue status and totals by cost center
• Partner with cross-functional team (e.g., finance, clinical execution, accounts payable, monitoring etc.) for general site payment issue resolution & support

Additional Skills:

• Familiar with the management of documents within a Trial Master File (TMF), preferred
• Previous experience and familiarity with the processing & tracking of study, site and vendor invoices and payments, preferred
• Verbal and written communication skills, attention to detail, and critical thinking
• Ability to work independently and manage one’s time
• Ability to apply accounting and mathematical principles to work as needed
• Clinical research background, familiar with clinical study process, monitoring, GCP and clinical study relevant regulations
• High compliance requirements and understand that rights and well-being of human subjects should be protected during clinical study

Education and Experience:

• Bachelor's Degree or equivalent in related field
• 0-2 years of experience required
• Experience in TMF document management systems, CTMS, and Coupa (Preferred)

Job Tags

Contract work,

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