Senior Clinical Research Associate I

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Accountable for managing and monitoring investigator sites assigned to them.

• Ensure that clinical trials are conducted in accordance with the Study Monitoring Plan, relevant laws, Good Clinical Practices, and Pfizer standards to achieve project objectives, timelines, and quality.

• Oversee the operational elements for the execution of clinical trial activities at designated investigator sites from site activation to database lock, ensuring that relevant timelines and quality standards are met.

• Act as the main point of contact for the assigned investigator sites throughout the study duration.

• Collaborate with the study team as necessary, facilitating the flow of information between study team members, vendors, and assigned investigator sites.

• Partner with SCP to perform development, coaching, and training for investigator site personnel to ensure ongoing compliance with the protocol and the safety of patients; this includes protocol training and addressing protocol-related inquiries from investigator site staff when necessary.

• Conduct onsite and remote/electronic monitoring as required for site initiation, routine monitoring, and site closure activities, ensuring compliance with the Study Monitoring Plan, SOPs, and adapting to emerging issues and technologies.

• Monitor site-level adverse events (AEs) and serious adverse events (SAEs), cooperating with the Drug Safety Unit and following up with investigator sites, as necessary, to resolve required information for SAE reports.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or a medical background, or equivalent.

• A minimum of 3 years of relevant experience in clinical research site monitoring, with some experience in Oncology.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

• Experience with global clinical trials.

• Must be proficient in English and in the native language(s) of the country in which they will be working.

🏝️ Benefits

• Significant travel (60-80%) within the area is required.

• May involve some international travel and occasional weekend travel.