Covance Start-up Associate in Warsaw, Poland
Covance is probably enhancing your quality of life without you even knowing it. We play an important role in bringing new therapies to market by helping to turn raw compounds into safe, effective, and approved drugs that help people live longer, more productive lives.
At the moment we are looking for:
Study Start- Up Associate
This is a full time, permanent, office based position, location Warsaw
About the Job:
Primary contact with investigative sites during site start-up activities with responsibility for collection of the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations
Maintenance of allocated site’s information in the Trial TrackerTM Site Information Module study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
Working with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.
Final review and approval of regulatory documentation for sites managed by another GSS professional (final independent review)
Where applicable, provide logistical support for clinical trial supply coordination
Education / Qualifications
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.
Previous experiance in the simillar position preffered (minimum 6 months)
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
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.).
Flexible and adaptable to a developing work environment
Fluency in local and English language
Job Number 2018-21832
Job Category Clinical Operations
Position Type Full-Time
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.