Summaiya Nisar

I've supported clinical research compliance and quality assurance at Minerva Research Solutions, strengthening regulatory processes, clinical trial data quality, and audit readiness across multiple therapeutic areas.

As a Compliance Specialist and Compliance Coordinator, I've contributed to SOP development, Regulatory QC and CRC reporting, PI oversight reporting, query oversight, root cause investigations, and trend analysis. I've also conducted Regulatory QA audits and reviewed delegation and training logs against protocol amendments and regulatory standards.

My work includes quality checks for patient eligibility, informed consent, study procedures, enrollment records, and eSource final reviews. I monitor CRC performance through compliance reporting on data-entry timeliness, query trends, and protocol deviation rates.

I've trained and supervised junior team members, developed prescreening templates and eSource documents, and performed risk-based monitoring across Cardiology, Pulmonology, Dermatology, Internal Medicine, Psychiatry, Nephrology, Endocrinology, and Obstetrics & Gynaecology.