Clinical Research Regulatory Coordinator (Remote)
DM Clinical Research (TEXAS CENTER FOR DRUG DEVEOLPMENT US)
Total years of experience :8 years, 1 Months
❖ Compile and prepare materials for submission to regulatory bodies,
ensuring timely regulatory compliance.
❖ Review clinical protocols to guarantee the collection of required data
for regulatory submissions.
❖ Observe and assess recruitment, enrollment procedures, and the consent
process to uphold ethical standards.
❖ Oversee safety monitoring and ensure accurate data collection and
analysis.
❖ Promptly report observations and findings to the Institutional Review
Board (IRB) and designated officials.
❖ Conduct quality control to ensure compliance with trial processes and
reliability of ongoing studies.
❖ Facilitate continuous improvement by supporting corrective and
preventive actions from external audit findings.
❖ Coordinate on-site visits, introductions, tours, EMR access, and
monitoring visits for efficient study execution.
❖ Assist the Regulatory team with the maintenance of electronic files in
electronic regulatory binders (Florence).
Responsibilities
❖ Oversaw and managed various clinical trial activities, ensuring smooth execution of research projects.
❖ Prepared study-related documentation, including adverse event reports, IRB documents, and progress reports.
❖ Collected and tracked regulatory documents for submission to central DRAP, NBC, and local IRB/SRC.
❖ Assisted in periodic review and revision of IRB secretariat SOPs to maintain compliance with regulations.
❖ Facilitated IRB meetings, preparing and distributing meeting agendas and minutes.
❖ Monitored study activities to ensure compliance with protocols and relevant local, federal, and state regulations.
Responsibilities ❖ Compile and prepare materials for submission to regulatory agencies. ❖ Review clinical protocols to ensure collection of data needed for regulatory submissions. ❖ Identify relevant guidance documents. ❖ Assists Regulatory team with maintenance of electronic files in electronic regulatory binders (Florence). ❖ Assists Study Team in completing study documentation according to ALCOA/ALCOA+ guidelines and maintenance of study files in accordance with regulatory guidelines. ❖ QC of assigned studies to ensure data safety and monitoring and to ensure QAR. ❖ Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits. ❖ Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. ❖ Provides guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies.
Responsibilities
❖ Coordinating the day-to-day activities of the research study. ❖ Actively recruits and formally consents study subjects for enrollment. ❖ Preparing documents for regulatory approval from the institutional review board (IRB), submits the interim and annual progress reports to Drug Regulatory Authority of Pakistan (DRAP). ❖ Managing calendars and conducts telephone, face-to-face interviews, or sends emails for follow-up visits as per protocol to administer assessment for data collection. ❖ Organizing and facilitates meetings, conferences, and other events associated with research activities. ❖ Documenting all correspondence and communication pertinent to the research and responded to study site monitoring visit findings and, after consultation with pi, implements approved recommendations. ❖ Maintaining documentation record of the investigational medicinal product received. Achievements and Award ❖ Successfully coordinated and helped execute five clinical research seven basic science studies at least given time through the full clinical research life cycle including recruiting subjects and study conclusions. ❖ Proactively communicated with peers, superiors, clients, and study participants. Displayed an ability to understand complex instructions and carry them out successfully. ❖ Consistently showcased the abilities required to manage daily clinical trial activities to include implementing policies, administering budget requirements, completing required reporting, and other administrative tasks. Audits and Monitoring ❖ Phase III CT ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) was inspected by the FDA. Together with the principal investigator, I was in charge of managing the audit activity. We conducted thorough reviews of the study procedures, including the protocol, patient information sheets, informed consent forms, CRFs, source data such as medical records, protocol deviations, and corrective and preventive actions (CAPAs) and SAEs. With certain observational findings, the audit of the site files (patient notes, pharmacy and drug records, signed financial documents/receipts, etc.) is effectively completed. ❖ The current Phase III Clinical Trial of the CanSino vaccine at Shaukat Khanam Memorial Cancer Hospital and Research Center was recently audited by the National Medical Products Administration (NMPA) of China. Being a part of this audit was an honour for me. Prior to audit, we have a strategy in place to assess study processes, SOPS, and trained research workers doing their assigned duties. With a few minor finds, we qualify this audit. ❖ The National Bioethics Committee (NBC) and the Pakistan Drug Regulatory Authority (DRAP) regularly schedule site audits; my PI assigned me the responsibility of ensuring that the site is prepared for the audit. We were able to state before the audit that our system was running at a suitable level of effectiveness, which helped us advance systems and procedures. ❖ Hospital audits were performed annually by JCI (Joint Commission International on Accreditation). Basic science research and the COVID-19 (CanSino) vaccine trial made the short list. With no findings, we successfully completed the audit after being completely prepared. ❖ Sponsors/CRO regularly arrange monthly and interim audits; these audits are controlled, and findings are addressed on the spot and in a timely manner.
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