Senior Clinical Trial Assistant- Summit NJ 07901

Senior Clinical Trial Assistant- Summit NJ 07901

Requirement: CELGJP00007930

 

Description:

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 90 of the Fortune 100 companies and found opportunities for more than 10,000 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®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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