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Responsible for independently and effectively managing sites to drive their performance throughout the lifecycle of the study, from site identification to study closure.
Act as single point of contact with sites and ensure compliance with all applicable regulations, Good Clinical Practices (GCP), and standard operating procedures (SOPs).
Perform site identification and selection, start-up, initiation, monitoring and close out in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions
Act as single point of contact with study sites, ensuring successful collaboration and meeting study expectations and milestones
Prepare ethics submissions and negotiate site contracts and budgets
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
Conducts continuous monitoring activities (both onsite and remote)
Identifies issues at sites; resolves issues and escalates as appropriate
Execute assigned work efficiently and adhere to project timelines and financial goals; review site performance metrics and make recommendations accordingly
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation
May conduct primary data collection at sites
May aid less experienced staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
May act as point of contact for other staff on project
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Strong knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Ability to anticipate potential issues and take appropriate actions with and / or without supervision
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPointAdvanced
communication skills and ability to influence others
Ability to manage multiple priorities and manage time efficiently
Ability to travel domestically (possibly internationally) as needed to study sites and meetings
Occasional overnight travel may be required
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s Degree, preferably in life science, and >
4 years of site monitoring and management experience; or equivalent combination of education, training and experience
Extensive use of telephone and face to face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time