Company: Novella Clinical Resourcing
Location: Stevenage, Hertforshire
Closing Date: 07 Jan 17
Type: Full Time
Salary (£): On Application
Benefits: Include pension, life insurance, medical insurance
Study Start Up and Document Management Associate vacancy at Novella Clinical. Full time, permanent and office based in Stevenage Hertfordshire.
Study Start Up and Document Management Associate
Novella Clinical (a Quintiles company) is a global, full service CRO with our European Headquarters in Hertfordshire, England.
We are currently looking for a Study Start Up(SSU) and Document Management Associate to work in offices based in Stevenage.
You will be responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study.
Principal responsibilities will include:
* May be asked to lead SSU activities and updates during weekly client teleconferences and internal team meetings
. *May interact with sponsors, clinical and contracts teams to discuss sites to be focused on for activation.
*May assist with the development of the study qualification questionnaires and may review protocols drawing on medical knowledge and regulatory expertise to interview sites for potential involvement in studies or trials
. *Creates and disseminates Confidential Disclosure Agreements (CDAs)/ Questionnaires to sites and follows up accordingly to ascertain interest and to meet study timelines
. *May review Informed Consent Forms and follows up with sites and sponsors accordingly
. *Assists sites with local IRB/ethics committee submissions
*Contacts sites directly, or through local CRA, as required to resolve issues before IRB/ethics committee submission and final review.
Required Knowledge, Skills and Abilities:
* Knowledge of clinical research process, ICH GCP and medical terminology.
* Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
. * Excellent organisational and interpersonal skills
. * Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
The vacancy is full time, office based and permanent.
To apply please follow this link below
Key words: study start up, document management, GCP, Hertfordshire, Stevenage
Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
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