Clinical Research Associate (m/f)

Basic qualifications:

Please see details.

Preferred qualifications:

Please see details.

Details:

GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer. This mission gives us the purpose to develop innovative medicines and products that help millions of people around the world. As a company, we also believe in developing talent and people. At GSK, you have the opportunity to make a real contribution in a dynamic and diverse business environment.

We are looking for a Clinical Research Associate (male/fermale) (Region Frankfurt-Mannheim-Karlsruhe)

Job Description-Job Objectives

The Clinical Research Associate (CRA) provides oversight of the study conduct activities at the investigator site level for clinical trials, ensuring patient safety and data integrity, presenting the customer-oriented and competent point of contact for investigators for GSK. This will include site development & training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites. This is completed in accordance with regulatory requirements, GSK operating standards and good clinical practices and in the course of international vaccine development adhering to the time frame of the development plan.

Activities/Tasks

  • Perform site evaluations and provide recommendations on site selection, study initiation, data monitoring and collection, patient recruitment and retention evaluation and site close-out activities for assigned sites.
  • Partner with Study Management and other relevant stakeholders to ensure optimal study conduct at assigned investigator sites in order to deliver on study objectives.
  • Proactively manage the Trial Master File and Country File to required SOP and regulatory standards. Ensure compliance with inspection readiness requirements.
  • Cultivate and maintain strong working relationships and communication with investigators, sites and GSK personnel.
  • Identify, escalate and resolve all monitoring and regulatory issues in partnership with investigator, site personnel and study teams.
  • Play a role in the development and implementation of efficient and effective approaches to study site management characterised by process standardisation, best practice sharing and continuous improvement, including taking over the "function of an expert".
  • Participate in monitors meetings, trainings relating to monitoring, GCP, SOPs, indications and technologies

Background and experience

  • Bachelor degree in medical, health and/or biological sciences or equivalent
  • 12 months as clinical trial assistant, clinical research associate or related role
  • The CRA role requires understanding of medical and scientific concepts and language in order to effectively interpret protocol requirements, understand medical notes and effectively conduct monitoring activities
  • CRA role is complex and requires the ability to balance multiple competing priorities, stakeholders and timelines. Familiarity with the basic language and process of sponsored clinical research is required.
  • In addition, knowledge of ICH-GCP and local regulations is critical for success in this role.
  • Communication skills, analytical skills (especially for Risk Based Monitoring), Influencing and negotiation skills; understanding of budgets and finance.

To become part of our team and develop a rewarding career please apply now at www.gsk-jobs.de. Req ID: WD122724!

Contact information:

You may apply for this position online by selecting the Apply now button.

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