Vijay Das
Cerritos,US
Summary
Motivated and methodical Senior Research Associate with extensive track record accomplishing research results to impact planning, innovation, and accountability. Proficient in data capture procedures and action planning. Strong organizational skills and data collection abilities.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate II
SYNEOS Clinical Research
Morrisville, US
04.2023 - 02.2024
- Served as primary point of contact for clinical sites, ensuring accountability for the overall quality and successful delivery of trials from initiation through close out
- Oversees trial conduct at designated sites to ensure compliance with approved protocols/amendments, GCP standards, and all applicable regulatory requirements while upholding the rights and safety of human subjects.
- Monitored safety events reported by investigators or found during monitoring visits.
- Prepared reports summarizing findings from monitoring visits.
- Provided guidance to junior clinical research associates regarding protocol adherence, CRF completion and other aspects of the clinical trial process.
Senior Clinical Research Associate
Parexel International
Billerica, US
05.2022 - 03.2023
- Monitored Phases I-III of Clinical Trials
- Responsible for site monitoring activities for all visit types including Pre Site Selection Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Close Out Visits (COV)
- Organized, participated and managed site protocol execution
- Managed various Electronic Data Capture (EDC) platforms (iMedidata, InForm, etc..) as well as Case Report Forms (CRF) to ensure data accuracy and completion.
Senior Clinical Research Associate
Specialist Staffing Services
Houston, US
12.2021 - 03.2022
- Executed site visits in line with contractual obligations and GCP standards for the pre, initiation, monitoring, and close out phases.
- Monitored and guided clients across various healthcare facilities
- Developed efficient channels of communication with clinical trial sites
- Supervised the development of assigned research initiatives, overseeing advancements in data collection, regulatory compliance, and site subject enrollment.
- Monitored safety events reported by investigators or found during monitoring visits.
Senior Clinical Research Associate
Labcorp Clinical Research
Austin, US
02.2021 - 11.2021
- Managed and monitored clinical sites to ensure proper site management
- Organized and presented Investigator Meetings for effective communication and collaboration.
- Played a role in the execution of protocols and the development of case reports.
- Monitored safety events reported by investigators or found during monitoring visits.
- Maintained accurate documentation of all on-site activities in the trial master file.
Clinical Research Associate II
IQVIA
Danbury, US
08.2019 - 12.2020
- Executed site visits for selection, initiation, monitoring, and closeout as outlined in contract and adhered to good clinical practices.
- Evaluated the quality and integrity of study site practices, ensuring compliance with applicable regulations and protocol guidelines.
- Communicated quality issues to relevant stakeholders including the Project Manager, Clinical Trail Manager, and Resource Manager.
- Provided necessary support and guidance to inexperienced clinical staff when required.
Clinical Research Associate I
ICON Clinical Research
North Wales, US
04.2018 - 07.2019
- Participated in a company-funded 90-day program that involved identifying, selecting, initiating, and closing clinical study sites. The program aimed to train highly motivated CRCs from the industry to transition into the role of CRAs.
- Supervised site-level execution of study protocols at designated clinical trial sites, maintaining adherence to ICH-GCP standards for the acquisition of accurate and reliable data.
- Developed and maintained necessary documentation for site management, monitoring, visit findings, and corresponding Action Plans or CAPAs.
Assistant Manager - Quality Control and Compliance
iScript Medical Transcription
Yorba Linda, US
07.2017 - 03.2018
- Maintained compliance with industry and customer service standards by evaluating client requirements and adhering to HIPAA regulations for medical/legal documentation
- Collaborated with quality control personnel, implementing procedures, systems, and standards of operation to enhance accuracy and proper documentation of medical visits, procedures, and therapies.
- Tracked regulatory submissions to ethics committees and regulatory authorities.
- Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
Clinical Research Coordinator II
City of Hope National Research Center
Duarte, US
11.2016 - 07.2017
- Overseeing various research projects related to hematological malignancies, specifically focusing on myeloma.
- Initiated and led investigator-driven IND trials across phases I-III
- Served as the primary point of contact for communication between the CRO/Sponsor and investigator
- Executed tasks including Informed Consent, subject documentation adherence, data collection, EDC management and biospecimen collection while adhering to ICH-GCP and IATA guidelines.
- Coordinated shipment of investigational product samples to sites.
- Participated in periodic conference calls with sponsor representatives.
Clinical Research Coordinator
Beverly Hills Cancer Center
Beverly Hills, US
11.2015 - 06.2016
- Managed the coordination of logistically challenging clinical trials related to solid tumors and hematological malignancies, including radiation therapy and chemotherapy
- Conducted feasibility assessments and pre-screened subjects to identify optimal participants for clinical trials.
- Facilitated effective communication between multiple CRO's and sponsor representatives regarding compliance with protocol requirements
- Worked alongside investigators to improve visibility and quality of a growing research center, providing enhanced services to the surrounding community.
- Coordinated shipment of investigational product samples to sites.
- Maintained accurate documentation of all on-site activities in the trial master file.
Clinical Research Coordinator
Innovative Clinical Research Institute
Whittier, US
10.2014 - 11.2015
- Coordinated and managed various studies in the fields of Heme/Oncology across phases I, II, and III.
- Participated in all visit types, ensuring accurate execution of clinical studies
- Managed and ensured compliance with protocols for the handling of Investigational Products (IPs), encompassing receiving, storing, dispensing, treating, monitoring accountability and organizing destruction.
- Ensured accurate EDC entry by calculating the BSA and collecting/verifying source data documentation.
- Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
Education
MD Degree -
University of Sint Eustatius School of Medicine
01.2009
Hyperbaric Medicine Certification -
EustatiusUniversityEustatiusEustatius School of Medicine
01.2001
Skills
- Site Management
- Monitoring visits
- Medical terminology fluency
- Site monitoring expertise
- Investigator relations
- Informed Consent Process
- Electronic Data Capture Systems
- Documentation requirements
- Good clinical practice
- Professional Demeanor
Activitiescertifications
- Avid sports enthusiast (baseball and football)
- Computers and Electronics
- Certified: United States Medical License Exam (USMLE) Step 1, Step 2, Step 2CS
- Certified: Educational Commission of Foreign Medical Graduates (ECFMG)
Skills
native speaker, fluent (conversationally), fluent (conversationally)
Therapeuticareaexpertise
Non-Small Cell Lung Cancer, 2014 - 2016, Colon Cancer, 2014 - 2016, Pancreatic Cancer, 2014 - 2016, Multiple Myeloma, 2014 - 2021, Leukemia, 2014 - 2021, Lymphoma, 2014 - 2020, CHF, 2014 - 2015, Hypertensive Disease, 2014 - 2016, Eczema, 2018 - 2019, Dementia, 2014, Ischemic Stroke Revascularization, 2012 - 2015, Vaccine Trials, 2019 - 2020
Affiliations
- Avid sports enthusiast (football and baseball)
- Computer and electronics
Languages
English
Native/ Bilingual
Hindi
Full Professional
Urdu
Professional
Certification
- United States Medical Licensing Exam (USMLE) Step 1, Step 2, Step 2CS Certified
- Educational Commission of Foreign Medical Graduates (ECFMG) Certified
References
References available upon request.
Timeline
Senior Clinical Research Associate II
SYNEOS Clinical Research
04.2023 - 02.2024
Senior Clinical Research Associate
Parexel International
05.2022 - 03.2023
Senior Clinical Research Associate
Specialist Staffing Services
12.2021 - 03.2022
Senior Clinical Research Associate
Labcorp Clinical Research
02.2021 - 11.2021
Clinical Research Associate II
IQVIA
08.2019 - 12.2020
Clinical Research Associate I
ICON Clinical Research
04.2018 - 07.2019
Assistant Manager - Quality Control and Compliance
iScript Medical Transcription
07.2017 - 03.2018
Clinical Research Coordinator II
City of Hope National Research Center
11.2016 - 07.2017
Clinical Research Coordinator
Beverly Hills Cancer Center
11.2015 - 06.2016
Clinical Research Coordinator
Innovative Clinical Research Institute
10.2014 - 11.2015
MD Degree -
University of Sint Eustatius School of Medicine
Hyperbaric Medicine Certification -
EustatiusUniversityEustatiusEustatius School of Medicine
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