GSS 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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GSS Specialist I

As a GSS Specialist you will be part of an enthusiastic global service group involved in the delivery of the Global Site Services (GSS) component of assigned studies globally.

You will be responsible for review of the required investigator documentation and study documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor working with investigative sites, CRAs and Ethics committees (EC) and you will be responsible for site start up and site maintenance.

Essential Job Duties:
•Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan
•Maintain and update document tracking information in the Trial TrackerTM Site Information Module and other tracking logs
•Assess impact of site personnel changes on regulatory documents and process/review new documents according to GCP/ICH guidelines
•Liaise with applicable IRB/IEC regarding investigator submission/approval issues as appropriate
•Setup and maintain investigative site files
•Understand and follow project specific and GSS policies and procedures
•Generate investigative site status reports for supervisor review
•Assemble administrative binders for study sites
•Perform other duties as assigned by management
•Assume responsibility for identifying key therapeutic area investigators (GP and Hospitals) and consultants for external feasibility
•Assume responsibility for negotiation of site agreements and budgets
•Develop and populate response spreadsheets from returned surveys; tabulate data into summary tables for incorporation into formal feasibility survey reports
•Assume responsibility for contacting and following with investigator sites regarding completion of confidentiality agreements and other information that may be required

Profile:
° 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)
° Good organizational and time management skills
° Good communication skills, oral and written
° Work well independently as well as in a team environment
° Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines would be an asset
° Working knowledge of study start-up/site activation
° Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills)

Covance's ongoing success offers team members unsurpassed growth and career development opportunities.

Covance is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries.

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

There is no better time to join us!
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) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 4 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:
• 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
• Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
• Good organizational and time management skills
• Excellent communication / writing skills
• Strong computer skills with an ability to access and leverage technology alternatives
• Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
• 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
• Ability to work independently
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