Ref #: 25512

Employment type: Fixed term - Full-Time

Location: Zuid Holland

Posted: 18-Jan-2021

Description

Responsibilities:

To support clinical trial sites and clinical team members in conducting clinical trials in accordance with the Company’s policies and procedures, relevant legislation and ICH GCP requirements whilst maintaining the standards of our company.

The In-House CRA is responsible for overall quality, completeness and timely processing of core, local Ethical and Regulatory documents, Trial Master File and Trial Management systems from site selection until site closure. Assists the Clinical Operations department in review/ translation of key clinical research documentation. Communicates with investigative sites and internal team members to predict timelines for site activation and ensure all activation requirements are met. Provides high level of customer service as first entry point of contact. Performs remote monitoring activities as agreed locally. Support local SRR activities where applicable. Other relevant trial, site or documentation related tasks as assigned by line manager. General administrative support e.g. coordination of meetings, travel arrangements, documentation and minutes of meetings.


Education & Experience

• Healthcare industry/ experience or customer service based employment
• Previous experience of monitoring trials in accordance with ICH GCP methodology
• Healthcare industry/ experience or customer service based employment

Previous experience of monitoring trials in accordance with ICH GCP methodology

Knowledge of clinical trial methodology
• Knowledge of the clinical trials environment – ICH GCP, regulatory issues, SOPs
• Knowledge of drug development process
• Good working knowledge of electronic clinical trials systems – IMPACT, EDC, IWRS, electronic TMF


Why this vacancy is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested?

Please submit your CV to iris.brouwer@docsglobal.com or apply via www.docsglobal.com. We are looking forward to your application!
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