Clinical Site Manager

Job Description

We are seeking a highly motivated individual to support multiple clinical studies as a Clinical Research Associate. The Contractor will perform monitoring and site management activities while ensuring patient safety, regulatory compliance, and high-quality data in accordance with applicable SOPs, study protocols, and ISO 14155 : 2020.

The successful candidate will conduct monitoring activities including visit preparation, on-site visits, follow-up, site contact, and report writing. They will also perform remote monitoring and interim site management as required. Additionally, they will support site start-up activities including EC / CA submissions / amendments, contract negotiation, and documentation preparation / collection.

Key responsibilities include :

• Conducting monitoring activities including visit preparation, on-site visits, follow-up, site contact, and report writing.
• Performing remote monitoring and interim site management as required.
• Supporting site start-up activities including EC / CA submissions / amendments, contract negotiation, and documentation preparation / collection.
• Attending study meetings and collaborating with cross-functional teams and study sites throughout all study phases.
• Ensuring monitoring of informed consents and site study files, including documentation for patients experiencing serious adverse events (SAEs).
• Reporting non-compliance of investigators with their Clinical Study Agreements (CSAs) to the Client.
• Finalizing monitoring reports within 28 calendar days of each clinical site visit.
• Supporting audit preparation and responses.

Requirements include :

Benefits

Working as a Clinical Research Associate offers numerous benefits, including :

Others

Additional details regarding this position include :