Clinical Research Associate
Resume:
Sameera Hasan
Washington State, U.S.
****.*******@*****.***
linkedin.com/in/sameera-h-63a0895a
Sameera Hasan
Trained as a Clinical Research Associate with 2 years of Remote and on-site Monitoring experience. I hold pride in my diverse work experience of 7 years in various Phases of Clinical Trials including Device Studies in Healthcare and Private settings. Experienced in Identifying, selecting, initiating and closing-out of investigational sites for clinical studies in phases II – IV. CIF and eTMF management Ensuring adherence to applicable regulations and principles of ICH-GCP. Skills:
• Clinical Trial Management: Proficient in overseeing the entire clinical trial process, from study start-up to close-out, ensuring that protocols are followed, and data is collected accurately and ethically.
• Regulatory Compliance: Thorough understanding of local and international regulations, guidelines, and ethical considerations governing clinical research, such as ICH/GCP guidelines and FDA regulations.
• Protocol Adherence: Skilled in ensuring that all study activities are conducted according to the approved protocol, and any deviations are documented and addressed appropriately.
• Monitoring and Site Management: Experienced in conducting site initiation, routine monitoring visits, and close-out visits, ensuring sites are trained, protocol compliant, and data quality is maintained.
• Data Management: Proficient in verifying source documents, ensuring accurate data entry into CRFs, and managing data discrepancies to maintain data integrity.
• Safety Reporting: Knowledgeable in adverse event and serious adverse event reporting, including proper documentation and timely reporting to regulatory authorities and ethics committees.
• Quality Control: Skilled in implementing quality control measures to ensure that data and study conduct meet the highest quality standards.
• Communication: Effective communication skills to liaise with site personnel, investigators, sponsors, and cross-functional teams. Strong writing skills for generating clear and concise monitoring visit reports and study-related documentation.
• Problem Solving: Experienced in identifying issues, discrepancies, and deviations from the protocol, and working collaboratively to implement corrective and preventive actions.
• Relationship Building: Proficient in establishing and maintaining positive relationships with site personnel, investigators, and study coordinators, fostering productive partnerships.
• Time Management: Skilled at managing multiple tasks and priorities, adhering to timelines, and ensuring study milestones are met.
• Adaptability: Ability to adapt to changes in study protocols, regulations, and evolving project needs while maintaining high-quality standards.
• Technical Proficiency: Familiarity with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other relevant software tools.
• Leadership and Training: Able to provide guidance and training to junior CRAs, site personnel, and investigators, contributing to their professional development.
• Risk Management: Skilled in identifying and mitigating risks associated with clinical trials, ensuring participant safety and study integrity.
• Problem-Solving: Capable of identifying challenges and implementing effective solutions to ensure smooth study conduct.
• Ethical Considerations: Thorough understanding of ethical principles and patient rights in clinical research, ensuring participant welfare and data privacy.
Sameera Hasan
Washington State, U.S.
****.*******@*****.***
linkedin.com/in/sameera-h-63a0895a
2 P a g e
• Analytical Skills: Ability to analyze complex data sets, identify trends, and contribute to data-driven decision- making.
Experience:
• Monitoring and Supervision: Monitored site activities to ensure compliance with protocols and regulations. Supervised data collection processes and ensured accuracy and completeness.
• Verified and Validated: Verified participant eligibility and medical history for study enrollment. Validated source data against CRFs to ensure data accuracy.
• Conducted and Performed: Conducted routine site visits to assess protocol adherence and data quality. Performed source data verification to confirm consistency between source documents and CRFs.
• Collaborated and Communicated: Collaborated with cross-functional teams to address site-related issues. Communicated study updates and protocol changes to site personnel.
• Managed and Organized: Managed site relationships by providing training and ongoing support. Organized and maintained regulatory documents and study files.
• Ensured and Assured: Ensured participant safety by monitoring adverse events and serious adverse events. Assured regulatory compliance through accurate and timely submissions.
• Trained and Educated: Trained site staff on study protocols, GCP guidelines, and regulatory requirements. Educated investigators on proper handling and administration of investigational products.
• Analyzed and Evaluated: Analyzed study data for trends and discrepancies, taking corrective actions as needed. Evaluated protocol deviations and recommended corrective measures.
• Documented and Reported: Documented monitoring visit findings and site activities in detailed reports. Reported adverse events and regulatory submissions to appropriate authorities.
• Supported and Guided: Supported site personnel with study-related queries and challenges. Guided sites in preparing for regulatory inspections and audits.
• Navigated and Adapted: Navigated complex protocols and adapted monitoring strategies as required. Adapted to evolving study requirements and changes in regulations.
• Reviewed and Audited: Reviewed essential documents and conducted site audits to ensure compliance. Audited study documents for accuracy, completeness, and regulatory alignment. Companies:
Clinical Research Associate
Cliantha Research Limited
Nov 2022 - Present
In-House Clinical Research Associate
DSCS Sweat Equity & Investments, LLC dba DSCS CRO
Oct 2019 - Dec 2020
Clinical Research Coordinator
Evergreen Health
Dec 2020 - Nov 2022
Clinical Research Coordinator
Clinical Services
Apr 2016 - Dec 2018
Aesthetic Laser Specialist
Laser soft clinic
Jul 2012 - Aug 2014
General Dental Practitioner.
Sameera Hasan
Washington State, U.S.
****.*******@*****.***
linkedin.com/in/sameera-h-63a0895a
3 P a g e
Private
Aug 2005 - Aug 2014
Associate Dentist
Dr Mustafa Haidermota and Associates
May 2011 - Jan 2013
Associate Dentist
Dr Arif Alvi hospital
Sep 2005 - Sep 2009
Dental Officer
Jinnah Postgraduate and Medical Center
Mar 2006 - May 2007
Education
A.T. Still University of Health Sciences
Master’s in public health, Research
2021 - 2024
CHEA and CEPH Accredited master’s in public health The CRA Academy
Certified Clinical Research Associate, Clinical/Medical Laboratory Science/Research and Allied Professions 2019 Clinical Research Associate Certification
Edmonds College
Phlebotomy, Health Services/Allied Health/Health Sciences, General 2020 - 2021
Licensed Phlebotomist
Baqai Medical University bachelor's in dental surgery 2001 – 2004
Licenses & Certifications:
Certified Clinical Research Associate - DSCS Sweat Equity & Investments, LLC dba DSCS CRO GCP - Institute of Good Clinical Practice
ICH Good Clinical Practice E6(R2) - The Global Health Network Member of the Association of Clinical Research Professionals - ACRP Association of Clinical Research Professionals Certified Dangerous Goods Professional (CDGP) - Mayo Clinic IATA - Mayo Clinic
Basic Life Support for Healthcare Providers (BLS) - American Heart Association Issued Jul 2020 - Expires Jul 2025
Medical Assistance-Phlebotomy - State of Washington Issued Jun 2023 - Expires Jun 2025
Medical Assistant-Registered - State of Washington Issued Jun 2023 - Expires Jun 2025
Covid-19 Contact Tracer - ASTHO and NCSD
Social and behavior research - CITI Program
Phrp - Protecting Human Research Participants (PHRP) Online Training, Inc. Clinical Dementia Rating - Knights Alzheimer's Disease Association Social and Behavioral Research - Basic/Refresher - CITI Program Issued Nov 2021 - Expires Nov 2025
Sameera Hasan
Washington State, U.S.
****.*******@*****.***
linkedin.com/in/sameera-h-63a0895a
4 P a g e
Facial and body laser aesthetician - IMA - Institute of Medical Aesthetics Issued Jun 2014 - Expires Jun 2018
C- implant - University of North Carolina at Chapel Hill LUMINEERS advance dental aesthetics - Zabadne sterling dental. Reference: Upon Request.
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