Start Up Specialist I Information

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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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Start Up Specialist I

• Review and Approve regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
• Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable
• Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable
• Review and approve investigative site specific patient informed consents for required elements
• Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites
• Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor
• Liaise with Sponsor and Covance regulatory regarding document submission requirements
• Maintain and update document tracking, site address and contact information in the Site Information
• Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines
• Assess impact of study amendments on Informed Consent and other study documents and revise and review/approve accordingly
• Prepare new investigator submission packages to Local and/ ot Central IRB /IEC
• Provide milestone information for incorporation into weekly analysis sheets
• Attend ongoing training in GCP, project specific requirements and as may generally be required
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 4 years work experience in clinical study start up including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
Experience   Required:

Minimum of 2 years work experience in Clinical Study Start Up

A working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
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