Senior Clinical Trial Assistant- Summit NJ 07901

Senior Clinical Trial Assistant- Summit NJ 07901

Requirement: CELGJP00007930



Completed BA/BS in directly-relevant discipline or equivalent experience required; At least 2 years’ experience as CTA or comparable operating experience in pharmaceutical, biotech, or CRO, required.

Summary/Scope: Candidate should have experience with: Insourced and outsourced studies Ability to work on 3 or more studies Experience with global studies Experience with different Phases, Oncology/HemOnc/II a plus Ability to work on routine to complex projects/trials


Responsibilities include, but are not limited to, the following:

Monitoring Visit Report Review Informed Consent Review IP Reconciliation Endpoint a plus but not required Oversee TMF Quality Review for study team

Complete TMF QC for department on a quarterly basis for each study Submitting documents to the TMF Creating and or reviewing study plans, specification documents, materials and tools

Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team, etc. Track study progress in CTMS including patient enrollment and patient status

Oversight of Regulatory documents. Provide access to systems when applicable Track and ensure training of study team. QC oversight of CRO Payments /Invoices Safety Alert acknowledgement oversight Support planning and logistics for meetings including investigator meetings, study team meetings, CRA meetings and meetings with CROs and other vendors

Generate, finalize and distribute study team agendas and meeting minutes. Assist with generating the CSR appendices Other: Working knowledge of ICH/GCP, regulatory guidelines and directives, and the drug development process


Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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