Annette Babu

Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the PI.

Managed multiple research studies simultaneously while ensuring accurate record keeping. Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.

Involved in prescreening, screening, contacting, and recruiting potential participants. Conducted visits in clinic, biospecimen processing, data entry, and IRB renewals.

Prepared oral medication for pediatric patients, compounded suspensions, and prepared IV electrolytes and sterile IV medication. Prepared study drugs on behalf of IDS for research patients and documented in the study file.

Heavily involved in patient counseling, provided drug information, treatment chart review, and ADR monitoring. Performed patient interviews and collected medical and medication history to avoid therapeutic duplication.

Activities and societies: Ward Round Participation, Patient Counseling, Drug Information, Treatment Chart Review, ADR Monitoring, Medication History Review and Reconciliation, Drug Interaction Analysis, Medication Error Identification and Reporting, Audits on Medicine Intending and Administration, Education to Nurses on Parenteral Administration, Patient Interviews, OBGYN Pharmacy Intern

Completed a Doctor of Pharmacy program, gaining extensive knowledge in pharmaceutical sciences and clinical practice. Participated in ward rounds, patient counseling, drug information provision, and adverse drug reaction monitoring.

Completed a program focused on clinical trials research, acquiring foundational knowledge and skills essential for coordinating clinical studies. This education complements practical experience in managing research protocols and data.