Overview

The Senior Clinical Research Associate - Oncology is a critical position within the Operations team and is assigned as a study lead to manage clinical trial studies. The Senior CRA will partner with a Project Manager to support activities on complex/larger trials and will work collaboratively with internal and external team members supporting project team activities and ensuring all study deliverables are completed on time and within budget. The Senior CRA will work to manage, oversee and may monitor/co-monitor clinical trial sites. Must reside in East South Central, Northeast Region or Midwest (U.S.)

Responsibilities

• 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/GCP guidelines and comply with company SOP's
• Review/approve vendor/site invoices
• Mentors junior members of the team

Qualifications

Experience / Education:

• Minimum of 5 years CRA experience in the pharmaceutical/biotech or CRO industry
• Minimum of 4 years of Oncology experience
• BS in a life science discipline is preferred
• Must have strong knowledge of ICH/GCP guidelines
• Comprehensive understanding of the drug development process
• Prior oncology drug development experience required
• Adept at managing/functioning within a cross-functional project team
• Strong interpersonal, communication and leadership skills
• Proficient with MS office
• High level of organizational skills, able to prioritize and manage tasks simultaneously
• Ability to work independently in a matrix environment
• Flexibility to accommodate changes in priorities and project needs
• Approximately 50% to study sites to monitor, co-monitor, train, attend Investigator meetings or conferences
• Masters, Bachelors, Associate, High school diploma or equivalent experience
• Preferred (Ex. AALAC certifications, SPHR)

Knowledge / Skills / Abilities:

• Proficient in oral & written communication skills
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Ability to stand/sit/walk for long periods of time
• Ability to Lift 10 lbs occasionally
• Ability to crouch, bend, twist, and reach

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.