Do you recognize yourself in below skills & competences:
- Clinical Trial Knowledge: in-depth understanding of study designs, operational processes, and regulations.
- Time Management & Prioritization: skilled in managing multiple studies, meeting deadlines and adapting to shifting priorities and competing demands.
- Communication Skills: clear, professional, and collaborative interaction with cross-functional teams, investigators, and sponsors.
- Problem-Solving & Decision-Making: proficient in identifying issues and making data-driven decisions.
- Leadership & Mentoring: experience in guiding junior CRAs and leading site and project activities.
- Relationship Building & Teamwork: strong at building partnerships with stakeholders and fostering collaboration across diverse teams.
- Adaptability & Attention to Detail: flexible in dynamic environments while ensuring compliance.
- Self-Motivated & Independent Worker: effective in independently managing site activities, monitoring responsibilities, and ensuring adherence to protocols and timelines.
In this role, you will have the opportunity to:
- Act as responsible person managing clinical study sites across various phases of the clinical study.
- Conduct qualification visits, site initiation visits, interim monitoring visits and close-out visits to ensure adherence to study protocols, monitoring plans and applicable other study plans and manuals, applicable standard operating procedures, and relevant regulations.
- Communicates regularly with investigators and site staff to provide guidance, support, and training about study-related matters to ensure compliance.
- Identify and escalate protocol deviations, non-compliance issues, and other risks to study integrity and subject safety and proactively address study-related issues and finds the appropriate solutions independently or in cooperation with project lead or project manager.
- Manage study supplies and oversee device accountability at sites.
- Facilitate communication and collaboration between study sites and other stakeholders, such as sponsor team, CROs, vendors and ethics committees.
- Interact with vendors as necessary.
- Actively participate in study team meetings.
The essential requirements for the job include:
- A Master of Science in a scientific, biological, or medical science field.
- Minimum of 2 years’ experience in clinical research or equivalent by education or relevant experience.
- Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook).
- Multilingual proficiency can be advantageous for international trials.
