Senior Clinical Research Associate

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• 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. • 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. • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. • Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. • Performs investigation product (IP) inventory, reconciliation and reviews storage and security. • 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. • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.

🎯 Requirements

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline. • Minimum of 3 years of on-site monitoring experience; 2 year oncology and Phase I experience preferred • High proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint). • Customer service demeanor; demonstrate flexibility and teamwork. • Ability to focus on detail for extended periods of time, high attention to accuracy. • Fluency in English communication, verbally and in writing. • Working knowledge of the drug development process. • Traveling required (60-70%).

🏖️ Benefits

• Precision for Medicine is not your typical CRO. • Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Opportunities for professional development.