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Belgium Keyrus Life Science

Clinical Research Associate

Job Description

As a Clinical Research Associate within Keyrus Life Science, you will join a team on client's site to ensure site management, and compliance monitoring. This position involves primary contact with health care professionals. As a CRA you must ensure that all activities will be conducted in accordance with National/International Regulations, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP).

Your main task will be on site by monitoring several visits and participate in the selection, initiation, monitoring and close-out according to Keyrus Life Science or Client SOPs. You will ensure, in compliance with GCP and SOPs, the quality, reliability and authenticity of data collected during monitoring and verify their source. You will be responsible for writing reports according to your visits on site and maintain the study files by ensuring the administrative follow-up. Moreover, you will review the clinical sites progress and initiate appropriate actions in order to achieve target recruitment objectives.

You participate in the preparation of submissions to ECs and be involved in the SAE (Serious Adverse Event) declaration and follow-up. You are responsible to manage everything that is related to the drugs towards the study: drug accountability, returns, storage conditions, resupplies request.

Last but not least, you actively participate in the investigator’s meeting and are fully managing the investigators and hospitals contracts, including negotiating the investigator fees and handling the hospital invoices.

Profile

You have a first experience (minimum 3 years) as CRA in Pharma/Biotech industry and during this experience you were already involved in the study start-up and EC submission in at least 2 countries. You have a university degree in scientific field and are familiar with ICH-E6 GCP guidelines. You have excellent interpersonal skills and are fluent in German and English. You are a fast-learner and are detail-oriented. You are able to work precisely as per procedures, rules and regulations and are very well organized. You can assimilate information and ideas from a wide source to make high quality decisions and can take a broad overview of the situation / problem or event.

What we offer

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Keyrus Belgium Offices:

  • Office Park - Drève Richelle 161 - Waterloo
  • Nijverheidslaan 3, - Strombeek Bever

Category

Clinical & Business operations

Location

Germany

Contact person

van Strien