Centralized Visit Report Reviewer II

Job Description

Precision Medicine Group is seeking a Centralized Visit Report Reviewer II to join their team. This role involves reviewing and approving site monitoring visit reports, ensuring consistency across protocols and SOPs. The reviewer will liaise with clinical monitoring staff, escalate issues, and actively participate in project meetings to improve report quality and resolve action items. They will also communicate trends, safety concerns, and support change management.Responsibilities:

• Review clinical monitoring visit reports for consistency.
• Liaise with clinical monitoring staff for timely report submission.
• Escalate open action items and protocol deviations.
• Attend project meetings and provide suggestions for improvement.
• Communicate trends, issues, and safety concerns.
• Complete necessary trainings.
• Support change management.
• Develop reporting tools and processes.
• Serve as a subject matter expert on visit reports.
• Identify areas of improvement in site monitoring performance.

Requirements:

• Bachelor’s Degree in a life science-related field.
• Minimum 3 years experience in clinical monitoring or clinical trial management.
• Working knowledge of ICH GCP guidelines.
• Effective communication skills.
• Excellent organizational and time management skills.
• Excellent skills in reviewing clinical monitoring visit reports.
• Ability to extract pertinent information from protocols and data systems.
• Ability to mentor junior team members.

The role offers:

• Opportunity to work with a leading clinical research organization.
• Chance to contribute to the quality and compliance of clinical trials.
• Collaborative and supportive work environment.