About the Role
The role involves leading clinical trial execution across multiple sites, ensuring adherence to protocols, timelines, and regulatory standards, with a focus on gastrointestinal therapeutic areas and cross-border collaboration.
Responsibilities
- Lead monitoring activities for multicenter clinical trials in gastrointestinal diseases.
- Ensure compliance with Good Clinical Practice (GCP) and applicable regulatory requirements.
- Conduct site initiation, routine monitoring, and close-out visits.
- Review source data and case report forms for accuracy and completeness.
- Serve as primary contact for investigative sites in bilingual regions.
- Prepare and maintain essential regulatory documents.
- Identify and resolve protocol deviations in collaboration with site staff.
- Escalate critical issues to project managers and sponsors promptly.
- Support development of monitoring plans and study tools.
- Train sites on study procedures, data entry, and safety reporting.
- Verify informed consent processes meet ethical and regulatory standards.
- Coordinate with central laboratories and supply vendors.
- Conduct risk-based monitoring strategies to ensure data integrity.
- Participate in audit and inspection readiness activities.
- Contribute to clinical study reports and submission documentation.
- Maintain up-to-date monitoring visit reports and trackers.
- Collaborate with cross-functional teams including data management and safety.
- Ensure timely query resolution with clinical sites.
- Support investigator meetings and training sessions.
- Track site performance metrics and enrollment progress.
- Assist in the development of study-specific monitoring guidelines.
- Review clinical data for consistency and protocol adherence.
- Facilitate communication between international sites and sponsors.
- Manage investigational product accountability logs.
- Support quality assurance initiatives across trial phases.
Compensation
Competitive salary and benefits package offered based on experience and qualifications.
Work Arrangement
Hybrid work model with a combination of remote and on-site responsibilities.
Team
Collaborative team environment focused on advancing gastrointestinal clinical research.
Therapeutic Focus
Specialized in gastrointestinal disorders including Crohn’s disease, ulcerative colitis, and other IBD-related conditions.
Language Requirement
Fluency in English and a second language such as French, Spanish, or German is mandatory for effective site communication.
Travel Expectations
Regular travel required, including cross-border visits to clinical sites across North America and Europe.
Professional Development
Opportunities for continuing education, conference attendance, and certification support are available.
Technology Platforms
Experience with Medidata Rave, Oracle Argus, and electronic trial master files is advantageous.
This position may require sponsorship for qualified candidates depending on location and eligibility.
