Senior Clinical Research Associate

Job Description

If you want to: 

• Join a multi-award-winning leading biopharmaceutical company 

• Be part of growing team of Clinical Research Associates  

• Use new technology and smart monitoring tools  

• Have flexibility of work and good work-life balance 

Apply today!  

On this position you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and actively develop and expand the territory for clinical research, finding and developing new sites.  

Your key responsibilities:  

• Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit & non-visit contact reports. 

• Ensure by monitoring activities that:  

  • Data generated at site are complete, accurate and unbiased. 

  • Subjects' right, safety and well-being are protected. 

• Perform clinical study site management/monitoring activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents. 

• Coordinate and manage various tasks in collaboration with other sponsor roles. 

• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. 

• Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed. 

• Manage and maintain clinical trial systems such as CTMS, eTMF, etc.  

• Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team. 

• Follow the country strategy defined by Country Director. 

You should apply if you have: 

• Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO. 

• Proven skills in site management, including management of site performance and patient recruitment. 

• Good IT skills, ability to learn and operate new IT applications.  

• Ability to understand and analyse data/metrics.  

• Capable of managing complex issues, works in a solution-oriented manner. 

• Fluent in English (verbal and written) and local language, excellent communication and presentation skills. 

• Good understanding and working knowledge of clinical research, local regulations, ICH-GCP. 

• M.A/ M.Sc degree with strong emphasis in medical/bioscience background. 

• Ability to travel domestically and internationally approximately 50% of working time. Expected travelling ~2-3 days/week. 

• Valid driving license. 

Current Employees apply HERE

Current Contingent Workers apply