Precision for Medicine, Oncology and Rare Disease is seeking a Clinical Research Associate II to support clinical research studies in Germany, focusing on ensuring patient safety, data quality, and regulatory compliance in clinical trials.
Requirements
- 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/or demonstrated competencies.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
- Experience monitoring in rare and complex therapeutic areas.
- Experience monitoring EDC trials and EHR records.
- Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
- Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
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.
- Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
- 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.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements.
- Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
Other
- Excellent communication and organizational skills are essential. A team player.
- Evidence of a client focused approach.
- Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.
- Fluency in English and for non-English speaking countries the local language of country where position based.
- Graduate or postgraduate degree.
