The Senior Clinical Research Associate is a critical position within the Boston Biomedical clinical team. The Senior CRA will work to manage, oversee and may monitor clinical trial sites. The Senior CRA will partner with internal and external team members to ensure clinical trial activities and deliverables are completed on-time and within budget. Assist in managing and or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
The Senior Clinical Research Associate (Sr. CRA) is a critical position within Boston Biomedical and is assigned as a "study lead" to manage clinical trial studies. The Sr. CRA may also partner with a Project Manager to support activities on complex/larger trials. The Sr. CRA works collaboratively with internal and external team members and supports project team activities to ensure all study deliverables are completed on time and within budget.
Reporting Relationship: Executive Director, Clinical Operations
- Participate in and may facilitate cross-functional study teams, liaise with other functional areas to accurately coordinate clinical study activities
- Coordinate clinical study timelines to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
- Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports
- Provide regular updates of study progression; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
- Participate in developing study plans; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
- Maintains project timeline, conducts risk assessment/mitigation and contingency planning.
- Tracks and reports project enrollment, builds and maintains study trackers, organizes and maintains meetings cross-functionally
- Supports/assists with oversight and accountability of all third-party vendors
- Reviews monitoring visit reports; liaise with monitors to understand any trends on quality issues or other site issues to develop solutions.
- Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
- Work on study feasibility assessments and selection of countries and sites for study conduct
- Create and conduct training sessions including investigator meetings and team trainings
- Provide oversight and direction to study team members, including vendors, for study deliverables
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP's
- Review/approve vendor/site invoices
- Mentors junior members of the team
- Minimum of 3 to 5 years CRA experience in the pharmaceutical/biotech industry
- BS/MS/PhD in a related life science discipline is appreciated Must have strong knowledge of ICH/GCP guidelines
- Comprehensive understanding of the drug development process
- Prior oncology drug development experience preferred
- Adept at managing a cross-functional project team
- Strong interpersonal, communication and leadership skills
- Proficient with MS office suite notably Project
- High level of organizational skills
- Demonstrated ability to work independently in a matrix environment
- Demonstrated ability to prioritize and manage multiple tasks simultaneously
- Demonstrated ability to influence through collaboration
- Flexibility to accommodate changes in priorities and project needs
- This position is not an onsite monitoring position but may require travel < 10% to sites to co-monitor/train, attend Investigator meetings, conferences etc.
Job Location: Cambridge, MA
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