Dr. Samreen Afroz Email & Phone Number

India

 Coordination & Training:  Collaborating, and consulting potential sponsors and CRO’s for increasing projects at site. Provided Project specific training to Study staff and ensured that all research activities were conducted according to protocols and in compliance with ICH-GCP Guidelines. Study Budget Preparation and Approval for Sponsored and Investigator Initiated Trials: Sponsor Budget:  Reviewing Shared budget from Sponsor and Discussing with the PI’s, Accounts department and other relevant departments for approval. Negotiation and Notification of changes to the draft budget, additional costs for newly introduced elements and approval.Investigator Initiated Trial Budget:  Calculating Study Startup Cost- IRB/IEC Dossier preparation, regulatory document preparation, IEC Annual Fee, Regulatory Fee, CTRI Registration, Institutional Overhead Charges, administrative fees. Preparing Break-up Per Patient: Procedures, Medications (Investigational Product) Cost, Transportation & Storage, Standard of Care cost, Travel Reimbursement, Laboratory Investigations, Insurance, compensation.  Documentation Cost: TMF, Database Cost, Review and Analysis. Cost of closing out the study (Archival Fee). Documentation: Ensured all the trial related documents for study approval and Monitoring are complete and up to date, complying with current regulations and standards.  Participants Screening, Recruitment & Selection Data Collection: Collected and Entered Data into Databases and Electronic Case Report Forms (eCRFs) provided by sponsor. Performed quality control checks on data by reviewing discrepancies reported by Data Management staff or generated from database queries. Inventory Management: Maintains responsibility for the management of the inventory for drug trials, orders, replaces and returns study materials, as required. Notifications: Timely Notification and Submission of necessary documents and events.

Worked as Assistant Professor of PharmD at KIMS Hospitals, for Students from St Pauls College of Pharmacy. Taught Pharmacotherapeutics, Clinical Pharmacy, Clinical Research and Toxicology Subjects. Carried out Hospital Preceptor duties of PharmD Interns at KIMS Hospitals. Edited course materials such as syllabi or lecture notes prior to their distribution. Design and conducted Research Projects, wrote manuscripts and published papers in National and International Journals.

India

 Completed Site Feasibility and Site Selection Duties. Ensured Study Subjects Safety and Confidentiality. Budget Preparation: Creating and overseeing trial budget for Trials by calculating the cost for Regulatory submission, IEC Annual Fee, Study team payment, Per Patient cost (Research Treatment, SOC, Investigations, Procedures, Travel Reimbursement, Insurance. Compensation), Documentation & Data Management Support, Archival. Study Compliance: Ensured that all research activities were conducted according to protocols and in compliance with ICH-GCP Guidelines. Prepared Trial Documents: Informed Consent Forms (ICF), Protocol, Clinical Trial Agreement (CTA), Budget, Site Standard Operating Procedure’s (SOP), Case report forms (CRFs), study logs and forms. Study Documentation: Maintains a Trial Master File (TMF) which contains Summary, Protocol, Study Approvals, Notifications, Dispensing procedures, Logs and Forms and any other relevant materials for each investigational Drug Trial. Data collection and Management:  Collected and Entered Data into Databases and Electronic Case Report Forms (eCRFs) provided by sponsor. Performed quality control checks on data by reviewing discrepancies reported by Data Management staff or generated from database queries. Informed Consent and Subject Enrolment:  Conducted screening interviews, Subject Enrolment, Co-ordinated patient visits, and tracked dropout details. Took vital signs, performed Investigations (ECG, PFT) and collected medical histories as part of study protocols. Investigational Product Inventory Management: Manage the inventory for clinical investigational drug trials and returned study supplies upon completion. Regulatory Notifications: Timely Notifications of Study Approvals, Amendments, protocol deviations, Study Status reports, Serious Adverse Events (SAE’s), Periodic safety updates reports (PSUR’s), Adverse Events (AE).

Doctor Of Pharmacy (Pharm.D.), Clinical Pharmacy, First Class With Distinction

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, First Class