Location: Maidenhead, United Kingdom
Closing Date: 04 Nov 16
Salary (£): Competitive
Attention graduates and all interested in CRO career! Covance UK is recruiting for a Global Site Services Assistant to help support Global Site Services team! This is a permanent, full time position, based in our Maidenhead office http://jobsearch.covance.com/jobs/1412461-Global-Site-Services-Assistant.aspx
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for our Clinical Operations team in Maidenhead and are currently seeking to hire a Global Site Services Assistant to help support Global Site Services team . This is a permanent, full time position, based in our Maidenhead office.
About the Job
Within this position, your duties will include:
- Collects the required investigator and local contact information to enter into Trial Tracker® Site Information Module.
- Responsible for maintenance of site address and personnel information in the study database of allocated country(ies).
- Where applicable distribute study specific information direct to investigative sites or to local monitors.
- Provide data entry support to Global Site Services; enter feasibility information or investigative site information (study supply shipping information / clinical study locations / site personnel)
- Liaise with investigative sites to facilitate retrieval of site start-up documentation.
- Provide administrative support to Global Site Services activities
- Assist in the collection, review, processing and tracking of regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP and ICH guidelines and the Investigator Package Plan
- Perform tracking and data entry activities related to feasibility assessments
- Assist in the review of investigative site specific patient informed consents for required elements
- Follow-up with investigative sites regarding document completion/submission
- Assist the liaison with assigned Regulatory Department (Covance, Sponsor or both) regarding document submission requirements
- Maintain and update document tracking information in the Trial TrackerTM Site Information Module and other tracking logs
- Assist in site documentation and site information maintenance activities
- Coordinate site address and contact information (study supply shipping information / clinical study locations / site personnel)
- Track study personnel changes and assist the processing of new documents according to GCP/ICH guidelines
- Revision of required study documentation as advised when study amendments occur
- Assist in the preparation of new investigator submission packages to Central/Local Ethics Committees as appropriate
- Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents/binders, mass mailings, filing, faxing/photocopying)
- Setup and maintain central project files and investigative site files as instructed
- Attend ongoing training in GCP, communication skills, and project specific requirements
- Understand and follow project specific Global Site Services policies and procedures
- Where appropriate liaise with Ethics Committee(s) regarding investigator submission/approval issues
- Support performance of quality reviews of documents in accordance with instructions of senior Global Site Services staff and relevant processes
- Assemble administrative binders for study sites
- Perform other duties as assigned by management
To be successful in this position, you will need to be educated related to administration or clinical research activities. Additionally, you will need to demonstrate:
- Excellent command of written and spoken English
- Basic 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
- Experience of Microsoft Word and Excel
- Good communication / writing skills
- Self-motivation with the ability to meet deadlines
- Works well independently as well as in a team environment
- Detail oriented
- Process oriented
- Good organizational skills
- Positive attitude and approach
- Interact with internal customers with professionalism and discretion
- Multi-tasking capability
The opportunity to work within an Experience d and highly skilled team.
Covance offers a comprehensive benefits package including health cover, contributory pension and life assurance.
Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
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. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
There is no better time to join us!
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
Maidenhead, United Kingdom
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