Medical Device Quality Assurance

Zeb Khan MSc.

*** ****** *** ****, **** Lauderdale, Florida USA 33325

***.******@*****.***

613-***-**** (Direct)

954-***-**** (Home)

PROFILE STATEMENT:

An experienced Clinical Research Lead with unparalleled problem-solving aptitude to drive global Phase I – IV pharmaceutical and medical device studies while envisioning immediate and long-term success, and maximizing research efficiency.

Key Aptitudes:

• Significant experience leading clinical trial initiation, tracking progress, and study close-out.

• Excellent oral and interpersonal skills in communicating with Federal Regulatory Agencies, Institutional Review Boards, site Investigators and research coordinators.

• Expert in drafting detailed Standard Operating Procedures (SOPs), Case Report Forms (CRFs), and professional data reports.

• Significant knowledge of IND, CTA, IDE, and ITA application submissions for investigational new drug or medical device research.

• Continuous learning and application of ICH-GCP, Canadian Food and Drug Regulations, and FDA Code of Federal Regulations Title 21.

WORK EXPERIENCE:

Clinical Research Lead | OHRI (Pharmaceutical, Medical Device, Health Care Industry)

January 2011 – Current

• Assigned to lead study initiation and manage progress for 9 single and multi-center clinical trials.

• Assured clinical studies adherence with ICH-GCP E6, OHRP, and U.S. & Canadian IRB guidelines.

• Reviewed and applied sections of FDA 21 CFR Parts 11, 312, 812 and Health Canada FDR Part C; in particular labeling, investigational testing of drugs and medical device, and reporting of SAE.

• Gained knowledge of FDA IND and Health Canada CTA submission for investigational drugs.

• Reported SAEs, AEs, and Adverse Drug Reactions under specified timelines.

• Advised investigators and trained research staff on SOPs, data collection and research protocols.

• Prepared detailed IRB applications, clinical trials amendments and annual study renewals.

• Negotiated contracts and budgets as well as inter-institution and industry Clinical Trial Agreements.

• Monitored data acquisition, reviewed data quality and reported data to management team.

• Improved research quality through implementation of policies from IRB and regulatory agencies.

• Designed CRFs and ICFs for clinical trials through consultations with multi-disciplinary stakeholders.

• Developed protocols for clinical trials, pilot studies, observational research, and quality assurance.

• Recruited staff for EDC software. Lead a team of 10-15 including investigators and research staff.

Clinical Research Assistant | Therapeutic Monitoring Systems (Medical Device Industry)

May 2009 – Current

• Advisor to CEO, CFO and CSO on regulatory approval for investigational testing of devices.

• Experienced with IDE and ITA submissions for investigational medical devices.

• Evaluated conformance to IEC/ASTM/AAMI/ANSI biosafety and performance standards for devices.

• Consulted on FDA 510(k) premarket notification, PMA and Health Canada Medical Device licensing.

• Drafted, reviewed and edited scientific manuscripts for publication in peer-reviewed journals.

• Assisted in writing and editing grant proposals for clinical trials.

• Awarded over $25K and managed $50K+ budgets to organize focused clinical trial meetings.

• Implemented creative initiatives to promote research collaboration and business development.

Clinical Trials Coordinator | OHRI (Pharmaceutical, Medical Device, Health Care Industry)

May 2009 – January 2011

• Consented patients through the informed consent process using ICFs and Investigator Brochures.

• Monitored patient follow-up visits, tracked medications and recorded any changes in medical history.

• Screened patient Inclusion/Exclusion criteria at enrollment and throughout later stages in trials.

• Recorded data on CRFs and EDC software from Source Documents and consultations with patients.

• Anticipated challenges at study initiation, problem-solved and administered thoughtful solutions.

• Maintained steady recruitment for clinical trials through planning and dissemination of study notices.

• Reported primary and secondary outcomes to investigators, research manager and stakeholders.

• Organized and labeled regulatory documents, approval letters, and electronic files.

• Randomized patients to therapeutic or placebo study arms.

• Documented study logs and records for Drug Accountability.

• Consulted with multi-disciplinary stakeholders to create an online Electronic Data Capture tool.

• Presented research concepts and data to scientific and general audience using MS Powerpoint.

• Retrieved and analyzed data using powerful statistical software packages SAS and SPSS.

• Advanced computer skills using Microsoft packages (WORD, EXCEL, ACCESS, OUTLOOK).

• Experienced with computer programming languages such as javascript, PHP, and MySQL.

Sole Proprietor | BioSense Consulting (Consultancy for advancing Biomedical Research)

June 2008 – May 2011

• Organized Biotech and medical science fairs for Eastern Ontario and National Canadian regions.

• Consulted with Sr. Executives from Sanofi-Aventis, BioTalent, and BioScience Education Canada.

• Multitasked several jobs including recruiting sponsors, marketing, and negotiating work terms.

• Researched and selected investigators working on innovative and translational medicine areas.

• Connected students with investigators and mentors to carry-out research proposals.

• Assisted students with preparation of study designs and methods.

RELATED WORK:

Research Associate. University of Ottawa Heart Institute. (2009)

Teaching Assistant. University of Ottawa Dept of Chemistry. (2006 – 2007)

Research Associate. FIU Laboratories. (2000 – 2004)

EDUCATION:

MSc. Biochemistry ǀ University of Ottawa, Ontario, Canada

2005 - 2008

Skills Acquired: GLP, GMP process, Intellectual Property, Drug-Receptor Interactions, Quality Assurance, Assay development, Proof of Concept, Scientific Writing, Critical Thinking, Apoptosis Research, Meta-Analysis, Literature Review, BioStatistics, Sample Size Calculation, Scientific Speech.

Awards: Entrance Scholarship, Ontario Graduate Scholarship, University Excellence Award.

BScH. Biological Sciences ǀ Florida International University, Florida, USA

1996 - 2000

Awards: Dean’s Honor List, Summa Cum Laude Honors (GPA 3.9/4.0).

TRAINING

• Pfizer GCP Training Course for Investigators and Coordinators

• OHRP Human Subject Assurance Training

• CITI Program: Collaborative Institutional Training Initiative

• OHRI Clinical Research Training Course Certificate program

• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

INTERESTS & ACTIVITIES

• Networking and Continuing Education through SoCRA, ACRP, conferences and workshops.

• Promoting business and research development between investigators and sponsors.

• Soccer – Sports and Social Club Co-ed Team League. Camping and Hiking Trails.

References Available Upon Request. United States Permanent Resident

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