Clinical Research Associate II - Senior Clinical Research Associate
3 days ago
🏡 Remote – Anywhere in California
Description
• The CRA II is a seasoned, experienced professional in monitoring and site management. • Responsibilities depend on the type and timing of the program to which the CRA II is assigned. • Typically includes activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. • Ensures patient safety is protected, quality of data generated by managed sites, resulting in low query levels and acceptable Quality Assurance reports. • Provides guidance at the site and project level towards audit readiness standards. • Offers support for audit and follow-up actions. • Updates, tracks, and maintains study-specific trial management tools/systems and status reports. • Assists in managing site start-up procedures including feasibility and recruitment of potential investigators. • Verifies informed consent process for adequacy. • Conducts all forms of site visits in accordance with protocol and local laws. • Documents activities via confirmation letters, follow-up letters, trip reports, and communication logs. • Reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. • Communicates effectively with site personnel and project management to relay protocol/study issues. • Develops and maintains good working relationships with investigators and study staff. • Performs investigational product (IP) inventory, reconciliation, and reviews storage and security. • Performs data review activities and assists with resolving data discrepancies. • Identifies and processes Serious Adverse Events according to study team procedures. • Identifies site risks and escalates them with suggested contingencies. • Prepares for and attends Investigator Meetings and sponsor face-to-face meetings. • Travels as necessary according to project needs. • Performs other duties as assigned by management.
Requirements
• Europe: 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. • N. America: 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. Site management or equivalent experience in clinical research • One year of oncology monitoring experience • Excellent communication and organizational skills are essential. A team player. • 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. International travel as needed. • Fluency in English and for non-English speaking countries the local language of country where position based
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance and disability benefits • Parental leave • Paid time off for sick leave and vacation
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