QuintilesIMS ISSC Associate - (UK office based) - Novella Clinical in United Kingdom
Novella Clinical (a Quintiles company) is a global, full service CRO with our European Headquarters in Hertfordshire, England.
We are currently looking for an Investigator Strategy and Site Coordination (ISSC) 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 Study 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.
The vacancy is full time, office based and permanent.
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.
Fluency in spoken and written English.