Ref #: 39113

Employment type: Permanent - Full-Time

Location: Home Based Germany

Posted: 30-Sep-2022

Description

Job Summary:

DOCS has partnered with a highly prestigious organization with one of the most robust pipelines and a proven track record as one of the most liked employers in the pharmaceutical industry in Germany. We are looking for interested and enthusiastic Starter CRAs who want to become a part of this family and add to the success story. Are you looking to start your career as a CRA? Then we would like to hear from you. If your application is successful we will train you and introduce you to the role of a CRA through structured trainings and learning on the job.


Roles & Responsibilities of the position:

The Clinical Research Associate will be responsible for monitoring local clinical studies and is the primary contact point between the sponsor and the investigational sites.
A successful candidate is after the trainings assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.


Key Responsibilities:


• Participates in site feasibility and/or pre-trial site assessment visits
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies
• Ensures site staff are trained, site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct and clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
• Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff




Job Requirements:

• You have a completed degree in Biology, Life Science or similar and you have successfully completed a CRA certificate
• Very good communication skills to establish and maintain great work relationships with sites and colleagues
• Highly self-motivated and flexible
• High proficiency in speaking and writing German and English
• Willingness to travel 2-3 days per week on average


What is offered:

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies and start your career as CRA in the industry
• 100% Home based
• Permanent contract
• Structured on the job training
• Great work atmosphere
• Compensatory time-off
• Contribution to pension scheme
• Company car or car allowance
• Travel time = work time


To apply:
Would you like to know more? We are looking forward to your application by either submitting your CV via email to anja.potrafke@docsglobal.com. We are looking forward to hearing from you.

#CRA job