Shiza Kamal
McKinney,TX
Summary
Dedicated clinical trials professional with a comprehensive background in coordinating and supporting various aspects of clinical research. Proven expertise in protocol adherence, patient recruitment, regulatory compliance, and data management. Committed to upholding the highest ethical standards in the pursuit of advancing medical research and contributing to the successful execution of clinical trials.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
Revival Research Institute, LLC
Michigan
04.2022 - 11.2022
- Ensure that clinical trials are conducted in accordance with the approved study protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines
- Collaborate with diverse cross-functional teams, including Operations, Training, Quality Management, Study Startup, Marketing, and Finance, to facilitate document control functions that support site operations
- Conduct internal audits to assess adherence to protocols, SOPs, and regulatory requirements.
- Prepare for and assist with external audits and inspections by regulatory agencies
- Maintained records of document control activities including version tracking, review cycles, archival dates in the electronic document management system (Realtime).
- Provide site-level training to clinical research staff on GCP guidelines, study protocols om electronic document management system (Realtime).
- Performed regular backups of electronic documents in accordance with data retention policy.
- Secure approval from clients or third parties before implementing master batch records, specifications, laboratory methods, protocols, and other cGMP documentation.
- Identify opportunities for process improvement and implement corrective and preventive actions (CAPAs) to enhance the quality of clinical research operations.
Regulatory Coordinator
DM Clinical Research
Houston, TX
11.2022 - Current
- Submits continuations and amendments as vital to maintain compliance with regulatory requirements and institutional policies
- Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study
- Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up to date
- Participate in weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments
- Coordinate strategies to improve existing standard operating procedures related to regulatory affairs
- Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality
- Provide training, mentorship and/or support to junior staff to ensure adequate regulatory compliance and critically evaluate incoming requests or issues.
Associate General Dentist
Oral Max
Karachi , Sindh
09.2021 - 11.2022
- Medical and dental history taking and clinical examination
- Developing digital radiographs, Scaling and Polishing, perform teeth extractions, RCT, impression taking, crown cutting, teeth whitening and orthodontics understanding.
- Performed comprehensive oral examinations and dental treatments for patients of all ages.
- Provided preventive, restorative, and cosmetic dentistry services including fillings, crowns, bridges, root canals, extractions and implants.
- Educated patients on proper oral hygiene techniques to promote overall oral health.
- Diagnosed and treated dental diseases such as periodontal disease, caries and malocclusion.
- Prescribed medications such as antibiotics and pain relievers when necessary.
- Maintained accurate patient records in accordance with HIPAA regulations.
- Conducted regular follow-up visits to monitor the progress of treatments.
- Evaluated results from diagnostic tests such as x-rays or bloodwork to determine appropriate course of action.
House Officer
Dow International Dental College
Karachi, Sindh
09.2020 - 09.2021
- Comprehensive clinical assessments in order to carry out treatment planning and management
- Interpretation of radiographs and results of various investigations to aid diagnosis
- Administrating effective local anesthesia
- Treating periodontal conditions with surgical and non-surgical techniques, along with manual and ultrasonic scaling and polishing
- Designing and fabricating complete and partial denture
- Crown cutting and impression taking
- Restoration of teeth and root canal treatment (manual and rotary) and post placements
- Extraction of third molar surgical and non-surgical
- Cephalometric tracing, placing orthodontic bands, bracket placing, changing ligature wires and taking records prior to orthodontic treatment
- Observed ansle forte I surgery, squamous cell carcinoma of tongue and squamous cell carcinoma of mandible.
Education
Bachelors of Dental Surgery
Dow University of Health And Sciences
Karachi, Pakistan01.2020
Skills
- MS Suite
- Diagnosis and Treatment
- Patient Examination
- Disease Prevention
- Quality Assurance
- Communications
- Care Planning
- Regulatory Compliance Oversight
- Project Management
- Problem-Solving
- Team Management
- Research Proficiency
Accomplishments
• Best Overall performance in orthodontics department
• Poster presentation -topic-Gum inflammation
Certification
- GCP
- IATA
- HIPPA
- ARCP training
- Basic implantology workshop
- Basic surgical skill workshop
Volunteer Work
- RANGERS MEDICAL CAMP
Provided Free medical and dental services and Awareness to underprivileged population held at barrister Shaheed Zulfiqar Ali Bhutto Law college layari.
- DENTAL OUTREACH PROGRAM FOR UNDERPRIVELEDGE SCHOOLS
Provided primary dental services, dental inspection, and awareness to students of elementary and middle school section.
Timeline
Regulatory Coordinator
DM Clinical Research
11.2022 - Current
Quality Assurance Specialist
Revival Research Institute, LLC
04.2022 - 11.2022
Associate General Dentist
Oral Max
09.2021 - 11.2022
House Officer
Dow International Dental College
09.2020 - 09.2021
Bachelors of Dental Surgery
Dow University of Health And Sciences
- GCP
- IATA
- HIPPA
- ARCP training
- Basic implantology workshop
- Basic surgical skill workshop
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