Senior Clinical Research Associate

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Ensure protocol compliance and quality
• Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure appropriate and timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with study-specific Monitoring Plans and training presentations
• Assist with ethics documents and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate monitoring visit reports documenting site problems, resolutions, actions, protocol deviations, study progress, and enrollment
• Ensure CRF data integrity through source document review and verification
• Perform quality control and verification of site documents for eTMF/TMF
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain contact with study sites to ensure protocol/GCP compliance and assess patient accrual
• Ensure compliance with ICH GCP, FDA regulations, and company/Sponsor SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with in-house CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Collaborate with other CRAs
• Assist in CRA new-hire training and onboarding
• Mentor CRAs
• Collaborate on the development and maintenance of the CTMS
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

• Minimum 3 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities
• Experience in Oncology
• Availability to travel
• Quality focused; Proven ability to be careful, thorough, and detail-oriented
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• Able to manage priorities, organize time and solve problems
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• Ability to travel
• Ability to manage stress
• Professional, trustworthy and disciplined
• Ability to problem-solve unstructured or ambiguous challenges
• Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
• Excellent communication and interpersonal skills with customer service orientation
• Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
• Self-starter who thrives in a collaborative, yet less structured team environment
• Knowledge of clinical research, ICH GCP and local regulations
• Knowledge of Regulatory and Ethical requirements
• Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
• EU: Graduation in a scientific health field
• EU: Adequate English
• Bachelor of Science (BS) in Biology, Biotechnology, Life Sciences, or Pharmacy