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.

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