An Overview of the Position

• Carry out monitoring and site management tasks to guarantee that sites are carrying out the study(s) and reporting research data in accordance with the study protocol, relevant regulations, and sponsor requirements.

Basic Operation

• Perform site monitoring visits (selection, initiation, monitoring, and close-out) according to GCP.
• Adapt, drive, and track subject recruiting plans with sites to improve predictability.
• Administer protocol and study training to assigned sites and establish regular communication to manage expectations and concerns.
• Evaluate study site practices pertaining to protocol behavior and rules. Appropriately escalate quality issues.
• Track regulatory applications and approvals, enrollment, CRF completion and submission, and data query development and resolution. Start-up support possible.
• Ensure site papers are filed in the Trial Master File (TMF) and the Investigator’s Site File (ISF) is kept according to GCP and local regulations.
• Submit periodical visit reports, follow-up letters, and other needed study paperwork to document site management, visit findings, and action plans.
• As needed, collaborate with research team members on project execution.
• If applicable, may support per-site project subject recruitment plan.
• Depending on the clinical trial agreement, may be responsible for site financial administration and invoice retrieval.

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Qualifications

• B.A. Science or healthcare degree recommended. Req
• Requires 2 years of on-site monitoring.
• Equivalent education, training, and experience may replace a degree.
• Good knowledge and application of clinical research regulations.
• GCP and ICH guidelines.
• Company-trained therapeutic and protocol knowledge.
• Computer skills, including Word, Excel, PowerPoint, laptop, iPhone, and iPad use (where applicable).
• Good written and vocal English skills.
• Organized and problem-solving.
• Time- and money-management skills.
• Effectively interact with coworkers, managers, and clients.