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Manager Regulatory Affairs

Location:
Chicago, Illinois, United States
Posted:
October 22, 2018

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Resume:

Curriculum Vitae

Hridi Hussain, BSc., MS

Address: Northwestern University – Division of Gastroenterology and Hepatology 676 N. Saint Clair Street, Suite 1400

Chicago, IL 60611

Phone: 847-***-**** (cell)

Email: ac7gnq@r.postjobfree.com

EDUCATION

Masters of Science in Regulatory Compliance – Concentration in Clinical Research June 2018 Northwestern University: Evanston, IL

GPA: 4.0

Bachelors of Science in Behavioral Neuroscience, Minor in Business Administration May 2013 Northeastern University: Boston, MA

Honors: Cum Laude, Dean’s List

EXPERIENCE

Northwestern University - Gastroenterology & Hepatology: Chicago, IL Jan 2016 - Present Manager of Regulatory Affairs: Inflammatory Bowel Disease, Short Bowel, Celiac Disease, Irritable Bowel Disease, Pouchitis, Eosinophilic esophagitis

Built research program in 2016 from having 33 studies open at one time to currently, 87 including investigational pharmaceutical clinical trials, retrospective chart reviews, biospecimen collection studies

Create and coordinate timely submissions of study documents (Protocol, Investigator Brochures, Informed Consent Forms, Patient Recruitment Materials, etc.) to Central and Institutional IRBs for both pharmaceutical-sponsored clinic trials and investigator-initiated studies in our department

Maintain IRB approval for existing studies through annual renewals, protocol amendments, administrative updates/addendums and reportable new information/adverse event.

Develop, process and track all regulatory documents to sponsors on behalf of the team (FDA 1572 forms, financial disclosure forms, IRB information, training certificates, etc.)

Compose informed consent forms, in addition to contributions to the protocol of investigator-initiated

Manage correspondence between the pharmaceutical sponsors, the IRB and all medical investigators involved for updates, changes and clarifications

Train new staff on regulatory and study coordinator roles and primary contact for PIs and study team members for FDA compliance within the department

Northwestern University - Neurological Surgery: Chicago, IL June 2014 - Jan 2016 Histology Specialist/Research Technician: Glioblastoma

Investigate anti-tumor therapeutics for treating glioblastoma using athymic mouse model

Maintain tumor cell cultures of patient surgical samples and established cell lines

Conduct animal-testing procedures including drug formulations, intracranial injections, dosing, anesthesia, euthanasia, organ-collection and necropsy

Collect and analyze in vivo and in vitro bioluminescence imaging of luciferase-modified tumor cells in response to therapeutics

Northwestern University - Neurophysiology: Chicago, IL Sept 2013 - June 2014 Research Coordinator: Chronic Pain

Recruited and screened patients into multiple clinical trials examining chronic pain improvement through dopaminergic modulators

Tracked daily input of pain maintenance and response to therapeutics for subjects

Conducted patient visits consisting of fMRI scans, drug compliance and pain maintenance

Compiled and analyzed behavioral data for later correlation to brain scan data The University of Chicago- Gastroenterology: Chicago, IL June - Sept 2013 Research Technologist: Inflammatory Bowel Disease

Harvard Medical School- Neurobiology: Boston, MA Jan 2012 - Jan 2013 Laboratory Technician: Reward Learning

PUBLICATIONS

Acknowledgments:

1. Oldenburg, I., Sabatini, B. (2015, June). Antagonistic but Not Symmetric Regulation of Primary Motor Cortex by Basal Ganglia Direct and Indirect Pathways. Neuron. 86 (5):1174-1181. 2015. PRESENTATIONS

Poster:

1. Tétreault P.1, Baliki M.1, Vachon-Presseau E.1, Hussain H.1, Farmer M.1, Baria A.T.1, Schnitzer T.2, Apkarian AV.1,3 (2014, March). Brain Functional Reorganization Following Duloxetine Treatment of Osteoarthritic Pain. IASP World Congress on Pain, Buenos Aires, Argentina. 2. Tétreault P.1, Baliki M.1, Vachon-Presseau E.1, Hussain H.1, Farmer M.1, Baria A.T.1, Schnitzer T.2, Apkarian AV.1,3 (2014, March). Structural Brain Modifications After Duloxetine Treatment-Related Pain Decrease. IASP World Congress on Pain, Buenos Aires, Argentina. Oral:

3. Tétreault P.1, Baliki M.1, Vachon-Presseau E.1, Hussain H.1, Farmer M.1, Baria A.T.1, Schnitzer T.2, Apkarian AV.1,3 (2014, November). Structural Brain Modifications After Duloxetine Treatment-Related Pain Decrease. Society for Neuroscience (SfN) Meeting, Washington, DC. in November 2014 LABORATORY SKILLS

Proficient in: cell culture, intracranial injections, cardiac and postmortem mouse perfusions, histology, in vitro and in vivo luminescence imaging, fluorescent microscope imaging, DNA/RNA extractions from blood and tissue, immunohistochemistry

CERTIFICATIONS

IATA Dangerous Goods Training – Northwestern University Good Clinical Practice – CITI program



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