1. Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) 2. Responsible for trial design and endpoint development in collaboration with Lead Clinical Scientist and Clinical Director 3. Co-Lead the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports. 4. Protocols/amendments – collaborate with MW 5. Author protocol clarification letters 6. Contributor to study specific documents (e.g., SMP) 7. Review/update informed consent 8. Provide scientific input to SM for data management activities (e.g., EDC, DRP, CRFs) 9. Monitor data issues requiring clinical input 10. Monitor central lab reports and other external data for safety and critical values 11. Provide clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO) 12. Prepare scientific slides, attends and presents protocol information at Investigator Meeting 13. Scientific co-lead on Clinical Trial Team (CTT) 14. Familiar with INFORM, JReview databases

Assist in clinical trials in oncology by networking with sponsors, activating new trials, submitting regulatory documents for review, enrolling patients, collecting data for EDC, and helping in reporting data to clinicaltrials.gov as needed. Creating presentations for grand rounds, poster sessions at national conferences, and meetings with sponsors. Writing protocols, consent forms, and clinical study reports for institutional trials. Collect and analyze data for retrospective studies. Use of SAS for statistical analysis. Enrolling patients in clinical trial and non-intervention studies. Data management. Monitoring and auditing of institutional clinical trials.

My primary interest is in helping authors write manuscripts, and edit their drafts for publication. Based on the requirements of the journal or the author, I will format documents to maintain consistency with styles, such as AMA, APA, Harvard, Chicago, CSE, etc. I am also interested in regulatory writing - protocols, consent forms, investigator brochures, clinical trial documents, clinical study reports, and any other documents pertaining to drug development. I have a good understanding of pharmacovigilance, and regulatory affairs pertaining to the US, Europe, and Indian authorities. I can review and edit grants, dissertations, and CME articles.