Precision for Medicine is looking to solve the problem of bringing life-changing therapies to patients by improving the speed, cost, and success rate of clinical trials, with a strong focus on Oncology and Rare Disease.
Requirements
- 3.5 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 required.
- Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
- Experience monitoring in rare and complex therapeutic areas
- Experience monitoring EDC trials and EHR records
- Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
- Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management.
Responsibilities
- Independently 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.
- Establishes, 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.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
- 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 data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
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.
- Good in English communication
