Clinical Research Associate
Intrinseque Health
Key Responsibilities
- Reviewing source documents.
- Verifying data in case report forms.
- Tracking patient enrollment and retention.
- Identifying and resolving site-level issues.
- Coordinating with investigators, site staff, and internal clinical operations teams to support trial start-up, ongoing conduct, and closeout activities.
- Assisting in site training.
- Preparation of monitoring reports.
- Management of essential documents.
- Communication of study updates to stakeholders.
Qualifications
- Strong expertise in clinical trial protocols and their practical implementation.
- Skills related to Clinical Research Associates functions and responsibilities, including site monitoring and documentation.
- Knowledge and experience in Clinical Trials, including study start-up, conduct, and closeout.
- Solid Research skills, including data review, analysis of findings, and documentation accuracy.
- Experience in Clinical Operations, including coordination with cross-functional teams and site management.
- Relevant academic background such as a degree in life sciences, pharmacy, medicine, or a related field.
- Understanding of GCP, ICH guidelines, and local regulatory requirements for clinical research.
- Strong analytical, organizational, and time-management skills, with attention to detail and ability to manage multiple sites or projects.
- Effective written and verbal communication skills, and ability to build collaborative relationships with investigators and site staff.