Clinical Research Associate / Late Development (m/w)
- Experience Level
- Experienced (non-manager)
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.
• 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
• You have already gathered 2 or more years of clinical onsite monitoring experience.
• Very good communication skills to establish and maintain great work relationships with sites and colleagues
• Proficient in speaking and writing German and English
• Willingness to travel 2-3 days per week on average
Remuneration & other details
• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
• Home based
• Perm contract with DOCS
• Friendly work atmosphere
• Compensatory time-off
• Contribution to pension scheme
• Company car or car allowance
• Travel time = work time
Interested? Please submit your CV to email@example.com. We are looking forward to getting to know you.