ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world, providing expertise in clinical operations and enhancing patient safety through real-world and clinical analysis.
In Short
Perform selection, initiation, monitoring, and closure visits at investigator sites.
Monitor activities at clinical study sites for adherence to GCP, ICH, SOPs, and study protocols.
Collect and review regulatory documents as required.
Prepare site visit reports and telephone contact reports.
Participate in the start-up process including reviewing protocols and developing study documents.
Resolve site issues and determine status for Investigational Product shipment.
Work with project managers and regulatory team members to secure authorization of documents.
Attend and present at investigator meetings and study-specific training meetings.
Participate in feasibility and site identification activities.
Assist the project team with the day-to-day management of clinical studies.
Requirements
Experience in clinical research and monitoring.
Knowledge of GCP, ICH guidelines, and regulatory requirements.
Strong communication and organizational skills.
Ability to work independently and as part of a team.
Proficiency in preparing regulatory documents.
Benefits
Opportunity to work with leading pharmaceutical and medical device companies.
Professional development and training opportunities.