Senior Clinical Trial Associate- Summit NJ 07901 Req. 7832

               

Senior Clinical Trial Associate- Summit NJ 07901

Req: 7832

Preferred skills: insourced and outsourced studies or Phase I/II studies focused on Hematology or Oncology

Skills/Knowledge Required:

Completed BA/BS in directly-relevant discipline or equivalent experience required. At least 3 years’ experience as CTA or comparable operating experience in pharmaceutical, or CRO required. Computer skills - MS office suite CTMS Sponsorview. Knowledge of databases EDC, IVRS, Central Lab, Central IRB

 

Summary/Scope:

The Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team. Responsibilities will vary slightly based on whether the study is insourced or outsourced, phase of the study lifecycle start up, maintenance, close out. Candidate should have experience with insourced and outsourced studies. However, experience with Phase 1/2 insourced studies with focus on Hematology/Oncology would be best suited for this role.

Responsibilities include, but are not limited to, the following: MVR Review ICF Review IP Reconciliation Invoice and Payment review, approval and reconciliation. Creating and or reviewing study plans, specification documents, materials and tools diary cards, visit assessment booklets, etc. 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 for site initiation. Provide access to systems when applicable. Track and ensure training of study team. QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines. Process and track payments to vendors and study sites as appropriate. Oversee TMF Quality Review for study team, complete TMF QC for department on a quarterly basis for each study Collecting, quality review and submitting documents to the TMF. Performing QC of TMF as appropriate. Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors. Generate, finalize and distribute study team agendas and meeting minutes. Assist with generating the CSR appendices and participate in SOP and WP development.

 

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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