Kavya Rudra Email & Phone Number

Kirkland, Wa, Us

Seattle, Washington, United States

• Lead study start up activities such site feasibility, site initiation visit for site selection and coordinating with the team to do Budget negotiations.• Managed the ICF consenting process and enrolling participants into studies.• Coordinated meetings between Investigator, study staff , site staff and prepared meeting minutes.• Prepared and maintained study binders such Regulatory, Source, pharmacy and laboratory binder.• Experienced in preparing and submitting 1572 , FDF and… Show more • Lead study start up activities such site feasibility, site initiation visit for site selection and coordinating with the team to do Budget negotiations.• Managed the ICF consenting process and enrolling participants into studies.• Coordinated meetings between Investigator, study staff , site staff and prepared meeting minutes.• Prepared and maintained study binders such Regulatory, Source, pharmacy and laboratory binder.• Experienced in preparing and submitting 1572 , FDF and essential other reports to regulatory authorities.• Collected and updated clinical data in electronic data capture systems like Rave EDC and Veeva Vault.• Experienced in preparing and reconciling invoices and budgets. • Prepared and coordinated central IRB submissions and communications• Coordinated and conducted study visits and activities, ensuring accurate data collection and resolving queries based on source documentation.• Led study startup activities, including budget development, contracting, and protocol implementation.• Effectively communicated with industry sponsors, physicians, and patients to ensure compliance and project success.• Coordinated research protocol monitoring and auditing, addressing deviations from protocol requirements to maintain research quality.• Developed and implemented study tools and source documents, maintaining regulatory compliance. Show less

• Successfully managed multiple projects and delivered high quality results. • Led cross functional study teams to successful completion of projects.• Collaborated with study team members to identify potential risks and update them in risk registry. • Planned, Organized, and monitored Project schedules.• Reported study progress to all key stakeholders.• Supported in reviewing project plan.• Managed project team meeting and shared meeting minutes.• Assisted in study… Show more • Successfully managed multiple projects and delivered high quality results. • Led cross functional study teams to successful completion of projects.• Collaborated with study team members to identify potential risks and update them in risk registry. • Planned, Organized, and monitored Project schedules.• Reported study progress to all key stakeholders.• Supported in reviewing project plan.• Managed project team meeting and shared meeting minutes.• Assisted in study management and start up activities.• Proactively identified project risks and presently potential solutions to the management.• Organized and delegated tasks to the team members.• Supported in development and review of study specific documentation.• Managed clinical trial data by using various software tools and databases to manage and track data.• Participated in clinical study team and vendor meetings.• Acted as a point of contact for multiple clinical studies.• Facilitated collection, processing, and disposition of project-related records.• Coordinated with cross functional teams to prepare and review protocols, study documents and case report forms.• Managed clinical data collection, database management and coordinated subject's confidentiality .• Successfully handled CAPA for timelines related issues. Show less

India

Hyderabad, Telangana, India

• Worked on image processing techniques across multiple modalities including but not limited to CT, MRI ,HRCT,PET,PETMIM,DXA,X-ray using proprietary software as well as other third party software• Worked on multiple HCC studies with complex scans of arterial, venous and delayed phases.• Worked on complex brain metastases studies which involves overlaying of each slice of brain scan series such T1,GADT1,T2,FLAIR with the standard using Brain magix software.• Trained team… Show more • Worked on image processing techniques across multiple modalities including but not limited to CT, MRI ,HRCT,PET,PETMIM,DXA,X-ray using proprietary software as well as other third party software• Worked on multiple HCC studies with complex scans of arterial, venous and delayed phases.• Worked on complex brain metastases studies which involves overlaying of each slice of brain scan series such T1,GADT1,T2,FLAIR with the standard using Brain magix software.• Trained team members on how to do quality checks on clinical reports before sending to the sites.• Performed project specific tasks in compliance with Good Clinical Practices (GCP) , regulatory requirements (21CFR Part 11),applicable departmental and companywide SOPs, and project specific protocols.• Demonstrated DXA expertise with experience of using Hologic and lunar software.• Acted as liaison with investigator site personnel to resolve issues that arose over the course of the clinical trial. Show less