STUDY START UP SPECIALIST / Sofia, Bulgaria
Location: Sofia, Bulgaria
Closing Date: 09 Feb 17
Salary (£): Competitive
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.
This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
We are currently seeking a pro-active GSS Specialist II to join our expanding CoSource team in Bulgaria.
About the job:
- 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
- Assist in review and approval of regulatory & investigator documents for study site activation and drug shipment trigger
- Assist in preparation of project specific plans for the GSS component of assigned studies
- Assist in review of core English patient informed consents for compliance to international requirements and protocol as applicable
- Assist in reviewof core Country patient informed consents for compliance to country requirements and protocol as applicable
- Assist in review of investigative site specific patient informed consents for required elements
- - 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
- - 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
- 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
- Good communication skills, oral and written
- 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
- Interact with internal and external customers with high degree of professionalism and discretion
- Multi-tasking capability
- Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training, capable of operating standard office equipment (e.g. fax, copier etc.).
- More than 2 years of Experience in the field.
THERE IS NO BETTER TIME TO JOIN US!
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.