Kash Jamalapurapu
Toronto,ON
Summary
Accomplished Clinical Research Associate with 8+ years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. In depth experience in Oncology Phase (I-III), FIH and Cardiovascular along with several other Therapeutic Areas. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards. Solid knowledge of GMP, ICH GCP E6 principles and local regulatory requirements.
Experience in 100% SDV, Risk Based Monitoring and Analytical Monitoring.
Overview
9
9
years of professional experience
3
3
years of post-secondary education
Work History
Principal Clinical Research Associate
PPD, Part Of Thermo Fisher
12.2022 - Current
- Managed site activation and project timelines, negotiating contracts ensuring prompt activation of sites.
- Coordinated and scheduled protocol-related visits both onsite and remote SDV along with ISF reconciliation and IP accountability and returns.
- Designed, Developed and assisted Protocols, Informed Consent Forms, Investigator Brochures and other study documents, patient recruitment strategies, creation of marketing materials and track revisions with Clinical Trial Manager
- Traveled to investigative sites to conduct site qualification, feasibility assessments, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Liaised between sponsors and sites to ensure seamless communication and project execution
- Developed process improvement plans to improve efficiency and reduce deviations in projects by ensuring compliance and training are up to date.
- Expert in various clinical systems such as CTMS ( Ex: Siebel, IMPACT etc), EDC (iMedidata ), eTMF ( Veeva, Box etc), IWRS (Suvoda, Signant etc), Safety Reporting ( SIP etc).m Supported in Set up of eTMF
Senior Clinical Research Associate II
PPD Part Of Thermo Fisher
07.2021 - 12.2022
- Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports
- Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team
- Followed drug storage procedures to comply with protocols and SOP requirements
- Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives
- Implemented strategies and plans to meet Data base locks, Interim Analysis and Data cut off and analyze data, and identify trends and potential risks
Senior Clinical Research Associate I
PPD, Part Of Thermo Fisher
02.2020 - 07.2021
- Assured compliance with local regulations, Code of Federal Regulations (CFR), ICH-GCP guidelines, and company/sponsor SOPs
- Performed source data verification according to contractual requirements. Assured timely completion and submission of case report forms (CRFs) according to clinical monitoring plan and/or data management plan
- Managed progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
- Designed work flow of remote monitoring in approving methodology as per different institutional policies
- Resolved project related problems and prioritized workload to meet deadlines with minimal oversight from management
Clinical Research Associate
Bright Labs
07.2016 - 08.2017
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
- Liaised with clinical project leader to effectively resolve study-related issues
- Created and maintained database and records filing system to document data on specimen collection, processing and storage
- Data entry into EDC system and IRT updates
- Planning, ordering of clinical supplies and managing inventory
Clinical Coordinator
Bright Labs
01.2015 - 07.2016
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
- Collected data and followed research protocols, operations manuals, and case report form requirements
- Maintained compliance with protocols covering patient care and clinical trial operations
- Followed informed consent processes and maintained records
- Planned, scheduled, and organized visit activities and updated documentation for subject visit
Education
Masters of Pharmacy -
JNTU
India 02.2013 - 06.2016
Skills
Corrective Action and Preventive Action
Timeline
Principal Clinical Research Associate
PPD, Part Of Thermo Fisher
12.2022 - Current
Senior Clinical Research Associate II
PPD Part Of Thermo Fisher
07.2021 - 12.2022
Senior Clinical Research Associate I
PPD, Part Of Thermo Fisher
02.2020 - 07.2021
Clinical Research Associate
Bright Labs
07.2016 - 08.2017
Clinical Coordinator
Bright Labs
01.2015 - 07.2016
Masters of Pharmacy -
JNTU
02.2013 - 06.2016
Similar Profiles
Strahil PanekovStrahil Panekov
Senior Finance Analyst at PPD, Part of Thermo Fisher ScientificSenior Finance Analyst at PPD, Part of Thermo Fisher Scientific
Skylar ReedSkylar Reed
Sr. Automation Specialist, Service at PPD, Part of Thermo Fisher ScientificSr. Automation Specialist, Service at PPD, Part of Thermo Fisher Scientific
Tiffaney SpruillTiffaney Spruill
Clinical Trial Coordinator at PPD Part of Thermo Fisher ScientificsClinical Trial Coordinator at PPD Part of Thermo Fisher Scientifics