Clinical Research Associate II

🕒 May 21

🏄 California, Texas – Remote

🏄 California – Remote 🤠 Texas – Remote

💵 $91.5k - $137.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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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 • Provides guidance at the site and project level towards audit readiness standards • Updates, tracks and maintains study specific trial management tools/systems • Manages site start up procedures including feasibility and recruitment • Assists the negotiation of study budgets and execution of investigator contracts • Verifies process of obtaining informed consent • Conducts all forms of site visits including pre-study, initiation, routine monitoring, and close-out visits • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs • Reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness • Reconciles contents of the ISF with the Trial Master File (TMF) • Communicates effectively and proactively with site personnel and Precision Project and Clinical Trial Management • Develops and maintains good working relationships with investigators and study staff • Performs investigational product inventory, reconciliation and reviews storage and security • Verifies issues or risks associated with blinded or randomized information related to investigational product • Performs data review activities including remote EDC CRF and patient profiles review

🎯 Requirements

• 4-year college degree or equivalent experience in a scientific or healthcare discipline • Two (2) years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies • Excellent communication and organizational skills are essential • Experience monitoring oncology trials • Evidence of a client focused approach • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail • Ability to travel overnight. Up to 60% travel on average, based on regional requirements • Fluency in English and for non-English speaking countries the local language of country where position based

🏖️ Benefits

• Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation • Discretionary annual bonus