Job Title: Clinical Monitoring Lead

Work Location:  MA

Summary:

This position offers an opportunity to lead and oversee clinical monitoring activities for pivotal clinical trials in rare disease, neurology, or oncology. The Clinical Monitoring Lead will ensure compliance with protocols and regulatory requirements, act as the primary liaison to clinical sites, and support the execution and quality of clinical studies. The role requires significant field travel and strong collaboration with cross-functional teams and vendors.

Responsibilities:

• Oversee and ensure compliance of study investigators and coordinators with protocols, GCP, CFRs, and IRB/EC requirements through training, guidance, and on-site evaluations.
• Serve as the primary point of contact for clinical sites, maintaining effective communication and support throughout the study lifecycle.
• Conduct co-monitoring visits with CRO CRAs, including site qualification, initiation, monitoring, and close-out visits, and generate timely, high-quality visit reports.
• Contribute to the development of study protocols, informed consent forms, case report forms, study plans, and clinical study reports.
• Maintain data quality and integrity by ensuring site compliance, reviewing data trends and audit reports, and implementing corrective actions as needed.
• Support documentation management in the trial master file (TMF), including monitoring reports, site correspondence, and device inventory records.
• Drive trial enrollment efforts, proactively identifying and addressing obstacles to participant recruitment.
• Collaborate with study management on vendor setup and oversight, support data review and cleaning, and participate in inspection readiness and mock audits.

Qualifications:

• Minimum 5 years of clinical research experience in complex pivotal rare disease, neurology, or oncology trials.
• Experience with clinical study vendor setup and management.
• Demonstrated support for audits and inspection readiness activities.
• Strong knowledge of GCP, FDA regulations, and IRB requirements.
• Proficiency with Microsoft Office Suite, EDC, and eTMF systems.
• Excellent project management, communication, and organizational skills.
• Ability to work independently and collaboratively within cross-functional teams under tight deadlines.
• Experience working with physicians and clinical staff; familiarity with hospital or clinical environments.
• Willingness and ability to travel 50% or more as required by the study.
• Bachelor’s degree (BS or BA) preferred, ideally in a scientific or related field.

Published Category: Clinical Operations & Development