Clinical Research / Trials Manager

ASIF I. QURESHI, M.D.

**** ******* ***.

Mansfield, MA. 02048-USA

Tel. Res: (508) - 339 1301

Off: (617) - 414 5729

Cell: (508) - 851 0042

Email: ********@**.***

Citizenship: U.S. citizen

EDUCATION:

Master in Clinical Investigation (2009-2011) – Thesis pending

Boston University -School of Medicine - Boston, MA, USA

MBA – (Marketing, Healthcare Management) (1999-2001)

Pak Lawrence University, Lahore-Pakistan

M.D. (1990-1997) : : Medicine, Surgery, Obstetrics/Gynecology, Ophthalmology, ENT

King Edward Medical University, Lahore-Pakistan

¬¬¬¬¬¬¬¬¬¬¬¬ AREAS OF EXPERTISE

Phase I-IV Clinical Trials IRB / WIRB Correspondence Therapeutic Areas include : Hematology / Oncology, Endocrinology, Neurology, CNS, CVS and Stem Cell

Protocol Development Patient Screening & Enrollment

FDA / ICH - GCP Guidelines Pharmacovigilance - AE & SAE

SOP development & Implementation Monitoring activities

PROFESSIONAL EXPERIENCE:

Boston University – School of Medicine - Boston, Massachusetts

May 2010 to date

Clinical Research / Trials Manager (Hematology / Oncology / Sickle Cell Center)

Directing, planning, and executing clinical trials and data collection activities, ensuring that clinical trials are carried out using principles of GCP/ICH, ensure that federal and institutional regulations are adhered to.

Clinical implementation of the global-multinational phase I-IV protocols within timelines and budgets

Monitor study conduct and progress (e.g. patient recruitment, protocol compliance, GCP/regulatory compliance).

Clinical science input to trial design & contribute to the development of protocols, monitoring plans, IBs, study agreements, individual study action plans, ICF & IRB approval process

Contribute to program level activities (e.g. development of clinical sections of regulatory documents, establish clinical procedures and recruitment strategies & responses to FDA/Health Authorities questions)

Participate in all conference calls and all study-related meetings; prepare agenda and minutes

Lead & matrix manage the cross-functional study team members (i.e. Regulatory, Site Managers)

Creating and maintaining CRF in hard as well as EDC (electronic data capture) files e.g. Inform, Oracle clinical

Provide medical input for development of promotional materials, manuals of operations & medical information letters

Boston Medical Center – Boston, Massachusetts

Sept 2006 to April 2010

Clinical Trials Manager

Manage all clinical operations for multiple clinical trials. Responsible for study execution including recruitment and enrollment strategies, oversight of monitoring activities, study conduct, compliance with regulatory standards, , and collection and completion of date.

Provide input and completion of the design and implementation of clinical protocols/amendments, informed consent forms, data collection systems, and annual renewals and reports.

Interact with various internal and external groups to facilitate the conduct of clinical trials (i.e. General Clinical Research Center, IRB, SDMC, Pharmacy, Vendors and FDA).

Assist in writing Grants (RO3, R15, R21) to different government agencies i.e. NIH, AHRQ, OSHA.

Track and manage studies to agreed timeline, budget and resources.

BOSTON NEURO-BEHAVIORAL ASSOCIATES, Dedham, Massachusetts

July 2003 to Aug. 2006

Clinical Project Manager

Provide management and leadership to plan, prepare and execute one (or more) high quality clinical project(s).

Manage and coordinate daily activities, multiple clinical tasks and ensure the effectiveness and smooth operations of the practice. Leads the clinical project team members toward completion of deliverables in a timely fashion within an agreed project timeline.

Negotiate managed care contracts for physicians, psychologists, and social workers.

Primarily responsible for interpreting ICD-9 and CPT coding of incoming referrals, including urgent, inpatient and outpatient admissions notifications.

Coordinate with AMR (American Medical Research Inc). Oak Brook, Illinois-USA for research related activities (e.g. patient recruitment, protocol compliance, GCP/regulatory compliance).

NOVARTIS PHARMACEUTICALS, –Pakistan

Jan 2001 to May 2002

Clinical Research Manager

Selection of Principal Investigator and clinical research site, facilitate budget/contract finalization.

Recruitment of qualified investigators, evaluation and development of study sites.

Ensure training is provided to project CRAs, both in GCPs and scientific aspects of therapeutic indication

Interface with corporate CTMs, Regional CRA Team and CRPs for operational input for feasibility, trial design/methodology, standard Pakistan medical practice and data capture.

Work with project team to assure successful completion of a trial in accordance with Ministry of Health regulations/GCP guidelines and SOPs.

Clinical supplies and logistics management & Consent form translations in local language.

CLINICAL RESIDENCY

April 97 - December 2000

Punjab Medical & Renal Transplant Center, Lahore-Pakistan

• Worked as an Intern, first on call for ICU where I managed post-op patients independently, which included fluid, electrolyte balance, inotropes adjustment and ventilation

• Assisted in major & minor surgeries i.e. Renal Transplant, Pyelolithotomy, Lithoclasty, Lap cholicystectomy &

hemodialysis. . Worked on ultrasonography based Lithotripter to break renal stones.

Mayo Hospital Lahore-Pakistan

• Working as an Intern I did rotations in various medical & surgical specialty e.g. ophthalmology, ENT, Neurology, Diabetic and Hypertensive Clinic, Urology, General Surgery, Chest Surgery. Learned basic techniques of anesthesia, maintenance and recovery from anesthesia, setting up IV lines, and endotracheal and chest tube Intubations.

TRAINING / CERTIFICATION:

• CRRO (Clinical Research Resources Office), Boston University, Boston, MA, USA

Fundamentals In The Conduct Of Clinical Research (2010)

New England Research Institute (NERI), Bethesda, MD, USA

Protocol Feasibility & Data Management Training Course (2009)

Clinical Research Site Training (CRST), San Francisco, CA, USA

How to Manage Clinical Trials Finances (2008)

Clinical Research Site Training (CRST), San Francisco, CA, USA

How to Coordinate Clinical Trials (2007)

Kriger Research Center, Inc. Boston- MA, USA

CRA Professional Development Program (2005-06)

Certification in ‘Human Participants Protection Education For Research Teams’ sponsored by NIH sep 2006

AWARDS AND HONOURS:

• Prize for the best Implementation of a study and Subjects Enrollment in clinical trial project (CHAMPS Study) at ASH (American Society of Hematology) Dec.2007 in Atlanta, GA.

• First prize for the best Implementation of a study and Subjects Enrollment in clinical trial project (NeuroPsych Study) at Sickle Cell / NIH Annual Conference Sep.2007 in Washington D.C.

• Merit Scholarship throughout Medical Education, 1990-97

• National Talent Scholarship in Pre-Med school, 1988-90

• Medal in King Edward Medical College Interclass Cricket Tournament, 1994

PROFESSIONAL PUBLICATIONS:

Publication:

Winfred Wang, Carlo Brugnara, Cathie Snyder, Lynn Wynn, Zora Rogers, Karen Kalinyak, Clark Brown, Asif Qureshi, Carolyn Bigelow, Lynne Neumayr, Kim Smith-Whitley, David Chui, Mardee Delahunty, Rob Woolson, Martin Steinberg, Marilyn Telen and Karen Kesler. The Effects of Hydroxycarbamide (Hydroxyurea) and Magnesium on Haemoglobin SC Disease: Results of the Multi-Center CHAMPS Trial. Accepted for publication by the British Journal of Haematology (BJH).

Acknowledgements of clinical study participation:

1- Elliott P. Vichinsky; Lynne D. Neumayr; Jeffrey I. Gold; et al.

Sickle Cell Anemia Abnormalities in Neurologically Intact Adults with Neuropsychological Dysfunction and Neuroimaging. JAMA. 2010;303(18):1823-1831

2- Carlton Dampier , Susan Lieff , Petra LeBeau ; et al. Health-related quality of life in children with sickle cell disease: A report from the Comprehensive Sickle Cell Centers Clinical Trial Consortium. Pediatric Blood & Cancer Volume 55, Issue 3, pages 485–494, September 2010

PROFESSIONAL AFFILIATION:

MassBio – Massachusetts Biotechnology Council

ASH- American Society of Hematology

SCD CRN- Sickle Cell Disease Clinical Research Network.

ACRP- Association for Clinical Research Professionals & IBPA- International Biopharmaceutical Association.

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