inVentiv Health Clinical Research Associate, Strategic Resourcing, The Netherlands in Flexible, Netherlands

Title Clinical Research Associate, Strategic Resourcing, The Netherlands

Job ID 12009

Job Status Full Time Regular

Position Overview INC Research/inVentiv Health are currently recruiting for a Clinical Research Associate. In this position you will be solely working for a major pharmaceutical client in The Netherlands.

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 across multiple phases and multiples therapeutic areas.

Responsibilities • 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

Requirements • Degree in a scientific or health care discipline

• Fluent Dutch 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

Branch/Location Office Office Based

City Flexible

Country Netherlands (Holland) [NL]

Region EMEA