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Associate Specialist, Clinical Research

Irvine, CA 92614

Posted: 09/09/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 614119 Is job remote?: No Country: United States

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)

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Irvine, CA

Take the next step in your career journey in the vibrant city of Irvine, California! Nestled in the heart of Orange County, this thriving community offers unparalleled growth opportunities and an unbeatable quality of life. With its close proximity to stunning beaches, world-class shopping at South Coast Plaza, a bustling culinary scene featuring diverse cuisine options, and cultural attractions like the Irvine Museum and Irvine Barclay Theatre, Irvine has something for everyone. Whether you're into outdoor activities in Irvine Regional Park or catching a game at the Angel Stadium of Anaheim or the Honda Center, this region has it all. Explore our job listings today and discover why Irvine is the perfect place to advance your career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.