This role involves the execution and oversight of local operational clinical trial activities, ensuring compliance with ICH GCP and country regulations. The position significantly impacts how a country delivers trial commitments and objectives, especially during the study, and requires independent decision-making and oversight of important clinical research activities. As a customer-facing role, it builds business relationships with investigators and external partners, representing the client.
Responsibilities
Accountable for performance and compliance for assigned protocols in a country, adhering to ICH/GCP, country regulations, client policies, quality standards, and adverse event reporting requirements
Serve as the point of contact for assigned protocols, proactively driving and tracking execution and performance of deliverables, timelines, and results to meet country commitments
Forecast country resource needs and manage budgets as delegated
Responsible for quality and compliance in assigned protocols within the country
Oversee Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs) on assigned projects
Oversee training compliance and perform quality control visits
Review Monitoring Visit Reports and escalate performance issues and training needs to functional vendors and internal management
Oversee associate CRMs assigned to the client and collaborate on training needs with functional vendors
Collaborate with functional outsourcing vendors, investigators, and other external partners
Oversee country and site validations, site selection, and recruitment in assigned protocols
Provide clinical trial education to sites
Serve as the country point of contact for programmatically outsourced trials for assigned protocols
Collaborate internally with local Pharmacovigilance (PV), Regulatory, Global Medical Affairs (GMA), and Global Human Health (GHH) to align on key decisions
Support local and regional strategy development consistent with long-term corporate needs in conjunction with the Country Research Director (CRD) and Regional Operations
Perform all other duties as needed or assigned
Requirements
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
Thorough knowledge of ICH Guidelines and GCP, including a basic understanding of regulatory requirements in other countries
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Thorough understanding of the drug development process
Fluent in local office language and in English, both written and verbal
Good organizational and time management skills
Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC, and other applicable regulations/guidelines
Familiarity with investigator start-up documents
Previous interaction with operational project team and investigative sites preferred
Excellent communication skills, oral and written
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in a team environment
Detail and process oriented
Positive attitude and approach
Ability to interact with internal and external customers with a high degree of professionalism and discretion
Multi-tasking capability
Good computer skills with good working knowledge of a range of computer packages
Ability to lead and develop junior staff
Flexible and adaptable to a developing work environment
Minimum of six to eight (6-8) years of clinical research experience
Important Details
Work environment: Client office as per assignment
About the Company
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
