- Conduct site qualification, initiation, monitoring, and close-out visits, ensuring regulatory and protocol compliance.
- Evaluate site performance, escalate serious issues to the project team, and develop action plans.
- Verify informed consent process, protect subject/patient confidentiality, and assess factors affecting safety and data integrity.
- Assess site processes, conduct Source Document Review, and ensure accuracy of clinical data.
- Resolve queries, guide site staff, and ensure timely query resolution.
- Utilize hardware and software for effective clinical study data review and capture.
- Verify site compliance with electronic data capture requirements.
- Perform investigational product inventory, reconciliation, and ensure compliance with GCP/local regulations.
- Review Investigator Site File for accuracy and completeness, reconcile with Trial Master File.
- Document activities per SOPs, support subject/patient recruitment and retention.
- Manage site-level activities, adapt to changing priorities, and ensure project objectives are met.
- Act as a liaison with study site personnel and participate in meetings and training sessions.
- Provide guidance on audit readiness standards, support audit preparation, and follow-up actions.
For Real World Late Phase:
- Provide site support throughout the study lifecycle.
- Abstraction activities, collaboration with affiliates, and training junior staff.
- Identify out of scope activities, suggest potential sites based on local knowledge.
Qualifications:
- Bachelor s degree or RN in a related field or equivalent.
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
- Strong computer skills and adaptability to new technologies.
- Excellent communication and interpersonal skills.
- Ability to travel up to 75% regularly.
