Clinical Research Associate

• Location: BRUXELLES
• Type: Contracting
• Job #15490

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.

Let’s look together at your first challenge with us!

Clinical Research Associate

Our partners innovate to bringtreatmentsto their patients that significantly improve their lives. Together with the government and other health partners they are working towardsqualitative, affordable and accessible healthcare.

As a Clinical Research Associate you will be the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. You will be responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, you will utilize and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.

What are your responsibilities?

• Responsible for relationship building and management:
  – Usher investigator sites through site activation and study activities from study start up to close out.
  – Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
  – Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
  – …
• Responsible for proactively providing local intelligence:
  – Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
  – Understand targeted site criteria as well as services delivered to target sites. Track that all such services are provided consistently and in a timely manner.
  – Develop a solid understanding of targeted site-specific/institution-specific requirements to apply this knowledge to future site activities or the development of new targeted site relationships.
  – …
• Accountable for study start-up, activation, and execution to plan for targeted sites:
  – Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
  – Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating functions to standardize processes and deliver activation in line with the targeted site strategy.
  – …
• Responsible for CRO and Study Management Interface:
  
  • Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Excellence Partner and Study Management.
  • …
• Responsible for process, standards, and oversight:
  – Responsible for site and monitoring quality, regulatory and GCP compliance.
  – Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
  – Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs.
  – …
• Protocol Site Oversight:
  – Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
• …
• Site and Study Management Interface:
  – Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.

• …

Who are you?

You have ascientific or technical degree in thehealthcare area along with extensive knowledge of clinical trial methodology. You have 7 years of clinical research experience and/or quality management experience. Solid knowledge of clinical development processes with strong emphasis on monitoring. Project management experience preferred in the clinical development area. You have the ability to adapt to changing technologies and processes. Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization. English, French and Dutchare required.

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

Are you interested? Apply now by clicking on the orange button!