Precision for Medicine, Oncology and Rare Disease is looking to hire a Clinical Research Associate II in Germany to manage and monitor clinical research studies, ensuring patient safety and data quality.
Requirements
- Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
- Experience monitoring EDC trials and EHR records
- Experience in biopharma or relevant therapeutic area
- Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
- Understands clinical trials methodology, including a working knowledge of protocols and indications being studied
Responsibilities
- Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- Updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
- Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
Other
- University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional.
- 2 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and and/or demonstrated competencies.
- Excellent communication and organizational skills are essential.
- A team player.
- Evidence of a client focused approach
