Senior CRA Specialist

1 week ago

Remote, Oregon, United States Parexel Full time

Join a team where our values align to achieve remarkable outcomes.

The Clinical Research Associate serves as the primary liaison for clinical sites, responsible for overseeing site quality and performance from the initial identification phase through to study close-out. This role focuses on fostering strong relationships with sites, ensuring accountability for site performance, and effectively managing the initiation process, patient recruitment strategies, compliance assessments, and problem resolution.

Key Responsibilities:

Start-up Phase (from site identification to pre-initiation):

  • Act as the main point of contact for assigned sites, ensuring quality and timely delivery during the start-up phase.
  • Develop and maintain relationships with investigators and site personnel.
  • Conduct feasibility assessments and manage site pre-qualification and qualification processes, including:
    • Preparation and negotiation of Confidentiality Agreements (CDA) and Clinical Site Agreements (CSA).
    • Conduct remote Qualification Visits (QVs).
  • Generate visit reports, utilizing judgment to identify and resolve site issues.
  • Develop and manage strategies for essential regulatory document preparation and submission.
  • Prepare and submit applications to Institutional Review Boards (IRB) and other regulatory bodies, ensuring timely follow-up until final approval is obtained.
  • Maintain accurate Clinical Trial Management Systems (CTMS) and ensure all documentation is submitted to the trial master file in accordance with project plans.
  • Identify and address site-related questions and issues promptly, including those related to activation timelines and patient recruitment strategies.
  • Facilitate site access to relevant study systems and ensure compliance with training requirements.
  • Participate actively in meetings, audits, and regulatory inspections.

Maintenance Phase (from initiation to close-out):

  • Serve as the primary contact for assigned sites, ensuring adherence to study protocols and addressing site issues as they arise.
  • Support sites with access to study systems and ensure compliance with training requirements.
  • Evaluate site staff assignments and implement corrective actions as necessary.
  • Address and resolve documentation and communication issues at sites.
  • Monitor site recruitment plans and collaborate with site staff to identify areas for improvement.
  • Conduct on-site visits, applying expertise to resolve issues and ensure compliance.
  • Review and follow up on site payment statuses and data entry queries.

Overall Responsibilities:

  • Ensure timely completion of project goals and maintain accurate updates in trial management systems.
  • Collaborate with team members to strategize efficient project planning and goal achievement.
  • Maintain compliance with ICH-GCP and relevant regulations.
  • Delegate tasks to administrative support as needed and provide guidance and feedback.
  • Demonstrate commitment to high-quality work and foster a positive work environment.

Required Skills:

  • Strong problem-solving abilities and initiative.
  • Excellent presentation and communication skills.
  • Ability to prioritize tasks and meet project timelines.
  • Proficient in Clinical Trial Management Systems (CTMS) and MS Office applications.
  • Ability to work effectively in a team-oriented environment.

Qualifications:

  • Significant experience in site management or clinical research.
  • Degree in biological sciences, pharmacy, or a related health discipline preferred.

Equal Opportunity Statement:
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.

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