Regulatory Affairs Assistant - Clinical Oncology Studies

Regulatory Affairs Assistant

Philadelphia, 19103

Contract with the potential to become permanent

 

 

Job Description

 

Entry level position with potential to become permanent that will be assisting the Regulatory Affairs Department with collecting, tracking and reviewing essential documents for accuracy and compliance for oncology clinical trials.

 

  • Set up and maintain clinical study files
  • Ensure study documents are archived based on the appropriate guidelines and policies
  • Review of study documents to ensure compliance with FDA, ICH and GCP regulations/guidelines

 

 

Qualifications

 

Applicant must have “hands-on” regulatory experience and working knowledge of FDA regulations, OHRP regulations, ICH and GCP guidelines, and document review.  

 

Degree: Preferred college degree but not a requirement.

 

 

Required skills include: 

  • Proficient in MS Outlook, Word, Excel and Access;
  • Strong organizational, verbal and written communication skills;
  • The ability to work independently.

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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