Posted in Other 8 days ago.

Location: Trenton, New Jersey

Job Description:

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a CTA in Parsippany, NJ

Role Description

  • Participate in the planning of a study or multiple studies with the CTM.
  • To be responsible for clinical study sites selection and to ensure these sites are qualified with FDA
  • Perform operation and administrative duties assigned by the CTM.
  • Review data in the electronic data capture system; enter and reconcile queries as necessary. May also be involved in query resolution. Assist in trend review.
  • Monitor site preparation, including sending regulatory document packages to sites.
  • Prepare training materials related to monitoring practices and procedures to be presented at monitor training meetings to ensure that the monitors are adequately informed of monitoring requirements and procedures.
  • Review site qualification monitoring visit reports to assess site eligibility to participate in the study.
  • Review monitoring reports throughout the study to ensure that sites are adhering to the protocol and to identify potential issues and propose solutions.
  • Review monitoring reports throughout the study to ensure that sites are adhering to the protocol and to identify potential issues and propose solutions.
  • Monitor ongoing progress of enrollment and other benchmarks at the investigative sites to assess adherence to the study protocol and timelines
  • Maintain the internal tracking systems, including budgets and expenditures.
  • Perform operation and administrative duties assigned by the CTM.
  • Facilitate responsible sites' audit and inspection.
Skills & Requirements
  • Bachelor's degree or above in Medical, Pharmacy or related areas.
  • With at least 2 year experience in Clinical Research and Monitoring..
  • Must have experience with site qualification, initiation, regular monitoring and site close-out visits.
  • Demonstrates an understanding of regulatory requirements including a working knowledge of governmental guidelines.
  • Must have knowledge of EDC system.
  • Must have good written and verbal skills to communicate effectively with investigators and departmental personnel about protocol related topics.
  • Must be able to present reports and updates at Project and Staff meetings (powerpoint)
  • Must possess strong technical skills and include a working knowledge of Microsoft Office.
  • Be familiar with the regulations of FDA, GCP and ICH-GCP.
  • Should expect to work under strong pressure and to travel frequently.
  • Excellent in communication skills and is expected to establish good relationship with the Investigators and other related site personnel.
Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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