Reference number: 14532
Senior Clinical Research Associate (Neurology)
Office or Home-based
Here at inVentiv Health Clinical we are currently recruiting for a Senior Clinical Research Associate to be based in Germany.
inVentiv Health: Work Here. Matters Everywhere.
Within this position you will be given the opportunity to focus on studies within Neurology (Epilepsy, Parkinson's disease) in phases II-IV and be possibly able to widen your expertise within phase I trials.
* 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.
* 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.
* Utilize knowledge and experience to suggest improvements and/or innovations; pursue ongoing systems improvements.
* Provide mentoring / training to less experienced staff. May perform Monitoring Evaluation or Quality Assessment Visits.
* 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, especially in Neurology studies
* 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.