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Covance Inc.
Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion, employees in more than 60 countries, and more than 11,000 employees worldwide. NONCLINICAL DEVELOPMENT(Toxicology, Research Products, Analytical Services) * Managed 443 compound development programs (>250 IND/CTA enabling), with over 100 different sponsors, which led to 41 IND/CTA applications in 2... Read More
Address | 210 Carnegie Ctr Princeton, NJ 08540 (609) 452-8550 |
Website | www.covance.com/ |
Holding | No Holding Details |
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Associate
The Associate in Global Site Services is and Entry Level position ideal for College Graduates with a Science Degree, and an interest in handling pre-study regulatory documents required for submission to Regulatory authorities in order to gain approval to activate clinical trial sites on an international level. This requires continuous interaction with clinical trial sites to collect, review, process, and track regulatory and investigator documents in accordance with ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan. They also assist in review of core English, Country and site specific patient informed consents for compliance to international requirements. The Associate maintains and updates document tracking information in the Trial TrackerTM Site Information Module and designs and generates standard and complex query reports from various databases to support requests for information. This position is office based at our headquarters in Princeton, New Jersey.
Education/Qualifications Required:
• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
Experience Required:
• High level of computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training.
• Strong organizational and time management skills
• Strong communication skills, oral and written
• The ability to interact with internal and external customers with high degree of professionalism and discretion
• Self-motivation with the ability to work under pressure to meet deadlines
• Works well independently as well as in a team environment
• Detail and process oriented
• Positive attitude and approach
• Multi-tasking capability
• Flexible and adaptable to a developing work environment
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Other Job Information
Vacancy type: |
Full Time | Contact Mode: |
not provided |
Fax: |
+1-302-6555049 | Contact Name: |
not provided |
Job Duration: |
not provided | Phone: |
+1-609-4524440 |
Email: |
not provided |
TalentOne Job Information
Healthcare Clinical Research Project Manager
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