Ref #: 24253

Employment type: Permanent - Full-Time

Location: Germany

Posted: 16-Oct-2020

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 CRA’s who want to become a part of this family and add to the success story.


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 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 already gathered a minimum of 1 year of clinical onsite monitoring experience
• Experience in conducting monitoring for early development studies phase I
• Ideally expertise in Oncology / Hematology
• Very good communication skills to establish and maintain great work relationships with sites and colleagues
• 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
• 100% Home based
• Permanent contract
• 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 timo.kindermann@docsglobal.com or apply via our career portal on www.docsglobal.com. We are looking forward to hearing from you.