Functietitel: Clinical Research Associate

Functieomschrijving:

inVentiv Health - Transforming Promising Ideas into Commercial Reality

Job Title:

Clinical Research Associate (CRA) - Belgium

Primary Function:

inVentiv Health clinical are currently recruiting for a Clinical Research Associate. In this position you will be solely working for a major pharmaceutical client in Belgium. As a CRA you are the central point of communication between the pharmaceutical company and the investigators for all clinical trial related activities to assure trials are conducted on time and budget, while fully GCP, ICH and SOP compliant. The activities are on multiple phases and multiples therapeutic areas.

Job Description:

The major accountabilities of the Clinical Research Associate are:

• · Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial
• · Assume ambassadorial role to facilitate communication between sites and key client line functions to increase value proposition to investigators
• · Facilitate preparation and collection of site level documents
• · Execute site initiation and training activities
• · Perform both on-site and remote monitoring visits according to monitoring plan
• · Manage drug supply at site level
• · Resolve site level update of technical systems (Clin Admin, EDC)
• · Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc)
• · Manage recruitment implementing appropriate contingency plans as needed
• · Assure continual CP, ICH and SOP compliance (informed consent process, source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training
• · Author study monitoring reports
• · Perform data query resolution process (both at site and with data management)
• · Execute site closeout activities
• · Act as a full responsible manager of assigned investigational sites

inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.

Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market.

If this role is not suitable for your experience but you have worked in clinical research in the industry and would like to discuss other roles, please contact us as well for other possibilities!

Experience and Education Required:

· Degree in a scientific or health care discipline

· Fluent Dutch, French and English (oral and written)

· Basic medical and business knowledge

· Desired one year experience in clinical research

· Understands and can apply knowledge of clinical trial designs to trial execution

· Knowledge and experience in international standards (GCP/ICH), international (FDA, EMA) and local regulations

· Expertise in communication, managing multiple priorities and computer literacy

· Enthusiastic and eager personality

Werkgever Naam: INVENTIV HEALTH CLINICAL

Werkgever adres:
INVENTIV HEALTH CLINICAL, Storkstraat 18 , NL-3833LB LEUSDEN, NEDERLAND

Vorm van contact: Irene Houtsma

Job korte beschrijving: Natuurkundigen en astronomen

Land: Nederland

Regio: Utrecht

Contractduur: Vast

Contract type: Voltijds

Ervaring: Tot 1 jaar

Bron van jobaanbieding:
VDAB, Openbare diensten voor arbeidsvoorziening, België

Hoe toe te passen: Overig - zie vrije tekst