SKILLS AND EDUCATION:

• School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor’s degree in life sciences preferred
• In general, candidates for this job would hold the following levels of education/experience:
• 2 years relevant experience in clinical site management
• Experience in study activation and site management is an asset
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
• Must be fluent in English, and the regulatory language of the appointed location
• Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
• Demonstrated knowledge of global and local regulatory requirements
• Demonstrated understanding of key operational elements of a clinical trial (e.g., study startup, conduct, close-out activities, reporting, etc.)
• Understand the quality expectations and emphasis on right first time
• Demonstrate compliance with all applicable company, regulatory and country requirements
• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
• Proven ability to work independently and, also as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Understand basic medical terminology, GCP requirements and proficient in computer operations
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Required to support multi-national team members, and flexibility in working hours may be needed occasionally
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POSITION PURPOSE:

• The Site Activation Partner (SAP) is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards
• The SAP will provide technical and logistical support to the Site Relationship Partners (SRPs) to deliver Investigator Initiation and Study Start Up

PRIMARY DUTIES:

Responsible for supporting the SRPs and investigator for Targeted Sites: