Fizza Hussain
San Francisco Bay Area,CA
Summary
Highly motivated clinical research professional with 10 years of experience in clinical development, including 5 years in oncology clinical trials. Expertise in project management, vendor management, safety, ethics and data integrity. Knowledge of FDA regulations, ICH guidelines and Good Clinical Practices.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Clinical Project Manager
Lumabridge
10.2022 - 12.2023
- Collaborated effectively with clinical teams to meet deliverables of assigned project(s) in various study stages (start-up, maintenance, or close-out)
- Regularly communicated with project team and led project team meetings to ensure timelines, resources, interactions, and quality are consistently maintained
- Effectively engaged investigators to meet enrollment target per timelines
- Prepared numerous clinical study documents such as patient informed consent form (ICFs), Clinical Monitoring Plan, Project Management Plan, Laboratory Manual, Investigational product manual, and review or contribute to other functional operational plans
- Proactively identified, communicated, and mitigated project risks throughout the study
- Led meetings and conference calls with Sponsors, vendors, investigators, and executive management
- Managed patient enrollment, including projections of IP usage and IP inventory management
- Periodically reviewed data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring
- Managed 3rd party vendors for on-time delivery and compliance with scope of work
- Trained CRAs, CTAs, vendors, and ensure that investigators and study coordinators are trained on study requirements
- Developed and monitored metrics to evaluate the monitor and site performance
- Ensured adherence to FDA regulations, ICH GCP, company SOPs and study protocols.
Clinical Trial Manager
Parker Institute for Cancer Immunotherapy
04.2022 - 09.2022
- Managed phase II immunotherapy clinical trial including timelines, budget, resourcing, execution, and delivery in line with company mission and deliverables
- Developed processes and workflows to ensure efficient implementation and evaluation of clinical trial
- Led cross functional study team and ensured timely delivery of project deliverables
- Managed trial vendor day-to-day activities
- Reviewed and approved Monitoring Visit Reports
- Contributed to development, review and approval of study documents including protocol, informed consent forms (ICFs), study plans (Clinical trial monitoring plan, Data review plan, etc.), clinical study reports (CSR) and IND AR
- Reported out on trial progress, milestones, and escalation of issues, as appropriate, to management and stakeholders as needed
- Contributed to development of clinical operations processes, Standard Operating Procedures and departmental documentation and initiatives
Senior Clinical Research Associate
Parker Institute for Cancer Immunotherapy
03.2021 - 03.2022
- Served as the clinical trial lead in planning and execution of phase II immunotherapy clinical trial(s)
- Managed trial vendor day-to-day activities
- Developed processes and workflows to ensure efficient implementation and completion of clinical trial
- Contributed to development of clinical operations processes, Standard Operating Procedures and departmental documentation and initiatives
- Provided study drug projections and worked with external partners to facilitate and ensure study drug supply needs are met
- Worked with relevant functional groups to provide and participate in development of study plans and finalization of study-team level documents for protocol implementation
Clinical Research Associate
Parker Institute for Cancer Immunotherapy
09.2019 - 03.2021
- Supported four immunotherapy clinical trials (phases I – II), including one platform trial. Trial lifecycle stages included feasibility, planning, startup, and closeout
- Performed general administrative functions such as clinical trial tracking, providing logistical support to Clinical Development management teams
- Tracked and managed distribution of non-clinical supplies throughout the course of the study
- Tracked and maintained study information and reports on study progress
- Oversaw IRB/IEC submission document collection and other supplementary documentation as appropriate
- Ensured completeness of the Trial Master File (TMF) in accordance with SOP requirements
- Maintained accurate tracking and reporting of study management data
- Coordinated study logistics, documents, drug shipments, enrollment, and safety reports
Senior Clinical Trial Associate
Dynavax Technologies
01.2019 - 09.2019
- Supported the Clinical Operations team in the design, planning and implementation of Phase I and Phase II oncology clinical trials
- Maintained a systematic monitoring visit tracking system and performed quality review of trip reports, confirmation letters, and follow-up letters to ensure compliance with protocol, regulatory standards, and SOPs
- Assisted in the review, amendments and distribution of key clinical trial documents (i.e informed consent forms, protocol amendments, investigator brochures, study management plan, regulatory documents, etc.)
- Maintained effective tracking systems and communication with internal and external vendors to ensure updates of appropriate regulatory documents
- Reviewed and submitted regulatory documents from clinical sites to Regulatory Affairs
- Collaborated with both the internal team and vendors to assist in all the site-level audits by identifying and tracking deliverables and ensuring CAPAs are executed
- Tracked and distributed safety reports (SUSARs) to CROs in a timely manner and produced a reconciliation report of SAE’s on a monthly basis
- Oversaw CRO dissemination of safety reports to global investigators/IRB/EC to ensure timeliness and accuracy
- Tracked site enrollment metrics, patient status and maintain a current contact and staff list
- Filed and uploaded relevant documents to the trial master file (TMF) on an ongoing basis
- Performed quarterly review of the eTMF and clinical development documents for completeness and accuracy
- Performed quality control review of the eTMF on site level, trial level, and country level for all essential documents as part of study closure activities
- Maintained files of clinical trial documents for ongoing projects and assisted in the archiving of CRO study files and legacy documentation
- Coordinated logistics for study meetings, CRO or vendors meetings, investigator meetings, kick-off meetings, etc., including the preparation, archiving and dissemination of meeting minutes.
Senior Research Coordinator
NYU Langone Health
03.2016 - 06.2018
- Served as project lead on a multi-site study in Neurology, studying epilepsy patients.
- Established clinical trial standard operating procedures (SOPs) and developed material transfer agreements (MTA/CTA), coded data dictionaries, questionnaires (E-CRF’s), informed consent forms, and assent forms for each cohort, and continued amendments to study protocol and related documents
- Recruited, screened, obtained written informed consents, and conducted sensitive, structured interviews with each subject and provided resources and counseling to bereaved family members
- Compiled and analyzed complex data
- Coordinated time-sensitive procurement of bio-specimen (human brain, blood, cardiac tissue, liver tissue) post-autopsy
- Managed all IRB submissions in a timely manner and maintained a Study Regulatory Binder and Trial Master File (TMF)
- Presented study progress to the ethics board, research team, executive board meetings, advisory committee meetings, and monthly study site meetings
- Managed and served as liaison between vendors, external sites and collaborations with universities, researchers, foundations, and advocacy groups worldwide.
Research Assistant
NYU Langone Health
08.2014 - 06.2016
- Performed all data management procedures and developed surveys, coded data dictionary, annotated Case Report Form (CRF) using Epidata, and questionnaires using Qualtrics
- Performed discrepancy review, data validation on variables collected
- Developed Scientific Protocol (RCT), informed consents forms, recruitment letters/flyers, Gantt charts, and subject log template according to IRB regulations
- Wrote NIH grant application using format of the PHS 398 form
- Wrote manuscripts using de-identified datasets, created a database in SPSS suitable for analysis, performed management and analysis of research data, made valid interpretations (from statistical output) and drew appropriate conclusions based on findings while also developing skills in demonstration of findings to develop graphical and tabular presentations
- Trained staff on regulatory (FDA/IRB) requirements, preclinical requirements, protocol design, study design, operational and data management requirements, safety reporting requirements and the ethical principles underlying the conduct of clinical trials
- Performed Medical Chart Abstraction for subject medical records and generated checklist to maintain completeness and organization of each chart consisting of pertinent documents relevant to study
- Extracted EEG reports/CD’s, EKG tracing and reports, Brain MRI reports, and pathology reports from paper medical records and PDF files
- Performed self-audit on all ICF’s and cross-checked subject and study coordinator signatures and dates
- Critically evaluated clinical research literature in both observational and experimental studies in relation to study design, sample size and power, application of statistical tests, validity of observed results, and clinical impact of the study on the field.
Research Intern
Stony Brook University
05.2011 - 05.2013
- Coordinated visual search and movement experiments studying visual cognition, visual attention, visual working memory, and eye movements made during visual search and scene perception in Eye Cognition Lab, Psychiatry Department
- Screened and obtained written informed consent from subjects and explained the purpose and procedures of the study and prepared enrolled subjects for testing with eye trackers and EEG
- Collected and analyzed visual movements and behaviors and performed statistical analyses using Microsoft Excel and SPSS
- Generated stimuli for use in experiments and engaged in discussion with research team to help design new experiments/stimuli
Education
Master of Science in Clinical Research -
New York University
New York, NYBachelor of Science in Biological Sciences -
Stony Brook University
Stony Brook, NYSkills
- Clinical trial planning and oversight
- Project management
- Vendor management
- Site management
- Data analysis and reconciliation
- Effective Communication
Certification
Certified Clinical Research Professional (CCRP) – SOCRA
Publications
- Chloe Verducci, Fizza Hussain, Elizabeth Donner, Brian D. Moseley, Jeffrey Buchhalter, Dale Hesdorffer, Daniel Friedman, Orrin Devinsky, "SUDEP in the North American SUDEP Registry: The full spectrum of epilepsies.", Neurology Jul 2019, 93 (3) e227-e236;
- O. Devinsky, E. Bundock, D. Hesdorffer, E. Donner, B. Moseley, E. Cihan, F. Hussain and D. Friedman, "Resolving ambiguities in SUDEP classification," Epilepsia, Vol. 59, no. 6, pp. 1220-1233, 2018
- J. Louik, K. Doumlele, F. Hussain, L. Crandall, J. Buchhalter, D. Hesdorffer, E. Donner, O. Devinsky and D. Friedman, "Experiences with premorbid SUDEP discussion among participants in the North American SUDEP Registry (NASR)," Epilepsy and Behavior, Vol. 70, Part A, no. May 2017, pp. 131-134, 2017
Timeline
Clinical Project Manager
Lumabridge
10.2022 - 12.2023
Clinical Trial Manager
Parker Institute for Cancer Immunotherapy
04.2022 - 09.2022
Senior Clinical Research Associate
Parker Institute for Cancer Immunotherapy
03.2021 - 03.2022
Clinical Research Associate
Parker Institute for Cancer Immunotherapy
09.2019 - 03.2021
Senior Clinical Trial Associate
Dynavax Technologies
01.2019 - 09.2019
Senior Research Coordinator
NYU Langone Health
03.2016 - 06.2018
Research Assistant
NYU Langone Health
08.2014 - 06.2016
Research Intern
Stony Brook University
05.2011 - 05.2013
Master of Science in Clinical Research -
New York University
Bachelor of Science in Biological Sciences -
Stony Brook University
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