Clinical Research Associate II - FSP

Job description

Precision for Medicine is not your typical CRO. We are passionate about supporting professional growth and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a midsized CRO allows you to have influence and impact when it matters most with support from direct line management. To support continued growth from our clients, we are hiring all levels of CRAs experienced in monitoring Oncology, Cardiology, or Lupus, Position Summary: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member. Essential functions of the job include but are not limited to: 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. If required, 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. If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appr…