Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out ofthe trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of humansubjects are protected, quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).Build relationships with investigators and site staff.Facilitate and support site with access to relevant study systems and ensure sites are compliant with projectspecific training requirements.Address and resolve issues at sites, including, questions, potential deficiencies in documentation,communication, and the need for additional training.Apply working knowledge and judgment to identify and evaluate potential data quality issues. Determine andimplement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable.Actively participate in Investigator and other external or internal meetings and audits & regulatory inspectionsas requiredCollect, review, and approve (if applicable) updated/amended site documentation, including regulatorydocuments as applicable.Review site recruitment plan in collaboration with the site staff on an ongoing basis.Perform and report on-site visits and remote contacts in accordance with the monitoring plan; this includesQualification and Initiation visits; apply judgment and knowledge to independently resolve site issues,questions and concerns.Assess & manage test article/study supply including supply, accountability and destruction/return status.Review & follow-up site payment status.Follow-up on CRF data entry, query status, and SAEs.Conduct on-site study-specific training (if applicable).Performed site facilities assessments

Experienced with Targeted Therapies and Immune Checkpoint Inhibitors trials (PD-1, PD L-1 and CTLA-4) inSolid tumors.Involved in training the sites on the study protocol, study related tools and systems, CRF completionguidelines and data management expectations.Supported the selection of potential investigators, preparation of EC submissions, notifications to regulatoryauthorities, scheduling of meetings and other tasks as appropriateAssured timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations.Supported all activities for study start-up from CDAs, feasibility questionnaire and feedback, PSVs,regulatory documents collection and submission to IRBs, contract and budget related follow-ups, trackers,templates, plans and SIVs etc

-Performed monitoring visits to assure integrity of the clinical data with respect to accuracy, accountability,document, and adherence to procedures through review of CRF’s source documents, medical records.-IVRS and TUMOR responses by RECIST (1.0) and RECIST (1.1) evaluated all the adverse events byfollowing CTCAE grading-Managed study completion activities including query resolution until DB lock, record archiving and sitecloseout activities.-Established and maintained strong relationships with assigned investigator sites, study coordinators andData Management team.-Tracked proper study documentation (IRB approval letters, Informed Consent materials, signed ClinicalStudy Agreements, Confidentiality Agreements, etc.).

-Provided regular updates on study progress to team members and stakeholders. Ensured clinical trials wereconducted in accordance with state and central regulations, GCP-Reviewed and collected regulatory documentation, communication with Sponsor/CRO-Performed source document verification against case report forms (CRFs) efficiently; Resolved issues withsite staff and ensured issues are documented in the report and follow-up letter-Assisted the project team with study specific documentation such as preparing study-specific procedures,completing status reports, creating study newsletters and merge letters-Assisted in the preparation, handling and tracking of Ethics/Regulatory submissions including the distributionand submissions of safety reports