Job Title: Sr. CRA Contractor

Work Location: South or West Regions 

Summary:

This contract role focuses on clinical research monitoring for rare disease, neuromuscular, and pediatric studies, requiring travel to multiple sites in the South and West regions. The position involves both remote and on-site responsibilities, supporting clinical trial operations and ensuring compliance with regulatory standards.

Responsibilities:

• Oversee and track study monitoring activities, including conducting and documenting monitoring/co-monitoring visits at assigned clinical sites.
• Collaborate in the development of essential study documents such as protocols, informed consent forms, case report forms, and study manuals.
• Manage site performance, resolve protocol and GCP/ICH compliance issues, and support subject recruitment and data management.
• Perform both on-site and remote monitoring visits, ensuring timely and accurate reporting and follow-up on site activities.
• Maintain and reconcile clinical study files, ensuring all documentation is complete, accurate, and uploaded within required timelines.
• Support site management activities, including training, query resolution, monitoring findings, and enrollment tracking, with regular review and updates.
• Provide mentorship and training to clinical operations team members, and assist with quality control checks and safety narrative drafting as needed.
• Ensure timely submission of timesheets, travel bookings, and expense reports, and complete all required training within specified deadlines.

Qualifications:

• Bachelor’s degree in a scientific discipline required; BA or RN with relevant experience considered.
• Minimum 5 years of experience in the pharmaceutical or biotechnology industry.
• At least 5 years of clinical research associate (CRA) monitoring experience.
• Experience with rare disease, neuromuscular, pediatric, CNS, or Parkinson’s studies preferred.
• Familiarity with post-marketing and standard of care studies, and FDA-regulated study environments.
• Proficiency with Medidata RAVE EDC, Medidata CTMS, and eTMF systems preferred but not required.
• Strong written and oral communication, organizational skills, and attention to detail.
• Ability to travel 1-3 days per week initially, then 1 day per week or month as needed; must be able to cover at least 5 sites in the South or West regions.
• Demonstrated ability to work independently with limited supervision and provide mentorship to junior staff.
• Working knowledge of federal regulatory requirements and Good Clinical Practice guidelines.
• Proficient in Microsoft Office applications.
• Physical ability to perform job duties with or without accommodation, including sensory perception and muscle coordination.

Published Category: Clinical Operations & Development