Job Overview
We are seeking a skilled Clinical Trial Associate to join our team. The successful candidate will be responsible for providing clinical trial capabilities in support of clinical development.
The associate will ensure investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out.
Responsibilities
* Site Activation: Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (CA) (where applicable), track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.
* Site Communication: Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
* Issue Resolution: Identify, communicate, and resolve issues.
* Regulatory Compliance: Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
* Process Efficiency: Leverage previous site / review board engagements to efficiently drive new work.
* Data Management: Populate internal systems to ensure accuracy of trial / site performance.
* Procurement and Financial Management: Understand and comply with procurements, legal, and financial requirements and procedures.
* Documentation: Populate Trial Master Files and libraries for future reference.
* Continuous Improvement: Provide feedback and shared learning for continuous improvement.
* Prioritization and Monitoring: Leverage trial prioritization and anticipate and monitor dynamically changing priorities.
Requirements
* Education: Bachelor's degree preferably in a scientific or health-related field.
* Knowledge and Skills: Understanding of the overall clinical development paradigm and the importance of efficient site activation, applied knowledge of project management processes and skills, appreciation of/compliance-driven environment, effective communication, negotiation, and problem-solving skills, self-management and organizational skills.
* Language Skills: Native Romanian speaker with fluency in English is essential for this role.
* Experience: Two years clinical research experience or relevant experience preferred.
What We Offer
Our organization offers a premium workspace across our campus, complete with flexible hybrid working options, healthcare, pension, and life assurance benefits, subsidized canteen, onsite gym, travel subsidies, and on-site parking.
Additionally, we offer In-house People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives enhance the career experience for our colleagues.