Site Start Up and Document Management Associate

Novella Clinical Resourcing
On application
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Job Summary:

If you have some clinical research admin experience, good ICH-GCP knowledge and know your way round a TMF this role may be of interest to you. Permanent, full time and office based in Stevenage, Herts.


Novella Clinical (a Quintiles company) is a global, full service CRO with our European Headquarters in Hertfordshire, England.

We are currently looking for a Site Start Up 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 Site Start Up 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 from a previous clinical research administration role.

* Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members. Must be fluent in spoken and written English.

. * 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.