Clinical Trial Specialist - FSP

Job Summary: 
As a member of a global study team, the Clinical Trial Specialist (CTS) is responsible for study management and monitoring of assigned projects in accordance with SOPs, Good Clinical Practice, International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines, local regulations and additional sponsor requirements.  The CTS will participate in company, departmental and project team meetings.  This position reports into Clinical Operations.

Summary of Key Responsibilities:

• Demonstrates study and clinical investigative site management according to Good Clinical Practices, ICH Guidelines, local regulations, and SOPs.
• Creates and provides input into study management requirements and tools, monitoring tools and manuals and training tools.
• Maintains thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
• Performs study oversight and study site visits to ensure regulatory and study requirements are being fulfilled.
• Reviews study records including case report forms, consent forms, and other materials, and is versed in remote monitoring approaches.
• Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols;
• Provides input, tracks progress, and works to implement corrective action plans for study and individual site recruitment and retention plans.
• Develops and maintains collaborative relationships with investigational sites study teams, CRO teams, and vendor teams.
• Produces quality and timely study documentation, including trip reports, tracking and site/sponsor communications in accordance with standard operating procedures.
• Maintains accurate and timely Sponsor/site communication and correspondence.
• Responsible for ensuring IMP and supplies accountability.
• Participates in company, departmental and project team meetings.

Requirements

• BS/BA degree required; degree in healthcare scientific field preferred.
• 3 years monitoring / CRO management or CRO oversight experience of clinical trials, including site management, in CRO or Pharma space.
• Knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data.
• Excellent written and verbal communication, problem-solving, and interpersonal skills.
• Strong attention to detail.
• Effective organizational and time management skills.
• Ability to travel up to 35%.
• Proficient with MS Office Suite (Excel, Word and PowerPoint), familiar with MS Project.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.