Participates in the planning and conduct of our client's clinical studies. Ensures compliance to the study protocol, Good Clinical Practices, applicable regulatory guidelines and the Client's Standard Operating Procedures. This position is mainly focused on site management related activities.
- Ensure projects are compliant with regulatory guidelines and clinical protocol.
- Review informed consent documents.
- Provide product/protocol specific support and training to internal and external clinical staff.
- Coordinate the start-up and follow-up of the study sites in collaboration with study team.
- Coordinate activities with study specific committees, vendors and core labs.
- Follow-up on findings from monitoring visits and audits.
- Review site compliance and raise issues to study management.
- Serve as a liaison to field and site staff.
- Contribute to process improvements.
- Minimum of 3 years clinical research experience. Excellent understanding of clinical research.
- Strong written and verbal communication skills and good interpersonal skills.
- Analytical and problem solving oriented mindset.
- Good organization and coordination skills.
- Sense of accuracy and attention to detail.
- Proficiency in MS Office Suite and relevant clinical applications.
- Ability to work in team and independently when necessary.
- Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).