Reference number: 16242
Clinical Research Associate II or Senior, FSP, Germany
Home or Office based
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
We are currently looking for experienced CRAs in Germany to join one of our client dedicated Monitoring teams. Within this full time permanent position you will have the opportunity to work on Neurology studies only.
• Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.
• Review completion of proper informed consent procedures.
• Ensure accurate data reporting via review of site source documents and medical records.
• Interpret data to identify protocol deviations and risks to subject safety/data integrity.
• Generate queries and manage resolutions with site personnel.
• Perform investigational product accountability as per the protocol and Study Monitoring Plan.
• Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.
• Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.
• Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required.
• Act as primary liaison with study site personnel.
• Enter data into tracking systems as required.
• Participate in the identification and selection of investigators and clinical sites.
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.
• Provide clinical and technical support for project team as required.
• May interact with representatives of client affiliates as per project requirements.
• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience in clinical research / clinical monitoring
• Solid clinical research experience with vast clinical monitoring experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Strong organizational skills
• Must demonstrate good computer skills.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• A good command of the English language both verbal and written
• Ability to travel as necessary up to 70% depending on assignment. Overnight and occasional weekend travel may be required.
• A competitive remuneration package with excellent benefits.
• A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization.
• The opportunity to work within a successful and rewarding environment.