• Ensuring regulatory, ICH-GCP and protocol compliance.

• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.

• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes

• Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations

• Conducts source document review and verification of appropriate site source documents and medical records

• Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete

• Manages reporting of protocol deviations and appropriate follow up

• Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP

• Conducts follow up for escalated adverse event monitoring (AEM) report queries

• Collaborates with primary Site Manager who will act as the primary liaison with site personnel

The Individual

• A minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite)

• Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience

• Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice

• Proficiency in local language is required

• English proficiency is required

• Ability to manage required travel of on a regular basis

Skills

• Networking and relationship building skills

• Ability to communicate effectively and appropriately with internal and external stakeholders

• Ability to adapt to changing technologies and processes

• Effectively overcoming barriers encountered during the implementation of new processes and systems

• Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization

• Identifies and builds effective relationships with investigator site staff and other stakeholders

• Must demonstrate good computer skills and be able to embrace new technologies