Qualifications
* Bachelor's degree in life science/related field, advanced degree preferred.
* Minimum of 4+ years in the clinical research industry.
* Proven track record in managing clinical trials and site monitoring.
* In-depth knowledge of clinical trial processes, GCP, and regulatory requirements.
* Strong organizational, leadership, and time-management skills.
* Excellent communication, problem-solving, and interpersonal abilities.
* Ability to handle complex issues and provide effective solutions.
* Capacity to work with and review large volumes of documentation and data.
* Ability to travel to and from clinical sites and manage site visit requirements.
* Combination of office work and travel to clinical sites, which may include healthcare environments and other clinical settings.
Responsibilities
* Plan and conduct routine monitoring visits to evaluate site performance and compliance with study protocols, GCP, and regulatory standards.
* Oversee and support site staff in the execution of the study, including resolving complex issues and ensuring adherence to timelines.
* Perform site initiation, interim monitoring, and closeout visits.
* Review and verify source data against case report forms (CRFs) and other study documentation for accuracy and completeness.
* Identify, address, and resolve data discrepancies and issues.
* Ensure that data collection processes are efficient and compliant with protocol requirements.
* Ensure that clinical trials are conducted in accordance with regulatory requirements, including FDA guidelines, ICH GCP, and local regulations.
* Prepare and review essential documents and study records, ensuring compliance with regulatory standards.
* Assist in preparing for and managing audits and inspections.
* Provide training and support to junior CRAs and site staff on study protocols, procedures, and regulatory requirements.
* Mentor and guide less experienced team members, fostering professional development and ensuring high-quality performance.
* Act as a primary point of contact for study sites, addressing complex issues and facilitating communication between site staff and the study team.
* Collaborate with the study team to provide updates on site performance, study progress, and any issues or risks.
* Coordinate with cross-functional teams to ensure that study milestones and deliverables are met.
* Prepare detailed monitoring visit reports and ensure timely submission of site documentation.
* Assist in the preparation of study documentation, including protocols, amendments, and study reports.
* Maintain organized and accurate records of monitoring activities and site communications.
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