- Monitor and manage clinical trials in-house to ensure compliance with regulatory requirements and study protocols.
- Perform site management activities including site selection, initiation, monitoring, and close-out visits.
- Coordinate with the clinical project team to manage timelines and ensure the delivery of project milestones.
- Assist in the preparation of study documentation, including protocol amendments, informed consent forms, and study reports.
- Ensure data integrity and consistency by conducting thorough data reviews and verifying source documents.
- Collaborate with cross-functional teams to resolve any issues that arise during the study.
- Maintain regular communication with study sites to provide guidance and support as needed.
- Ensure adherence to Good Clinical Practice (GCP) guidelines and company SOPs.
Qualifications:
- Bachelor’s degree in life sciences, healthcare, or related field.
- Previous experience in clinical research, preferably within a CRO environment.
- Strong understanding of clinical trial processes, regulations, and GCP guidelines.
- Excellent organizational and communication skills.
- Ability to work independently and manage multiple priorities.
