Clinical Research Associate III Senior

1 month ago

Austin, Texas, United States WuXi AppTec Full time
Job Summary

The Senior Clinical Research Associate is a critical position within the Operations team, responsible for managing clinical trial studies and partnering with Project Managers to support complex/larger trials.

Key Responsibilities
  • Coordinate clinical study timelines to meet critical milestones and escalate issues that may jeopardize timelines and deliverables.
  • Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports, and overseeing or managing clinical documentation and reports.
  • Participate in developing study plans and preparing 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, and maintain clinical study files per ICH guidance.
  • Manage project timeline, conduct risk assessment/mitigation, and contingency planning, and track and report project enrollment.
  • Support/assist with oversight and accountability of all third-party vendors, review monitoring visit reports, and liaise with monitors to understand any trends on quality issues or other site issues.
  • Participate in preparation of vendor requirements and project scope and selection of study vendors, and effectively manage interactions with vendor study teams.
  • Create and conduct training sessions, including investigator meetings and team trainings, and 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 SOPs.
Requirements
  • Minimum of 4 years experience as a Clinical Research Associate in the pharmaceutical/biotech or CRO industry.
  • BS in a life science discipline is preferred.
  • Must have strong knowledge of ICH/GCP guidelines.
  • Comprehensive understanding of the drug development process.
  • 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.
Preferred Qualifications
  • 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, and Abilities
  • Proficient in oral and 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.
Equal Opportunity Employer

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.

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