Najeeba Ali14018 Cobalt Glen, Sugar Land, TX 77498

2005nali@gmail.com281-677-8462/832-894-4712

EXPERIENCED CLINICAL STUDIES PROFESSIONAL

Summary:Performance driven Cinical Studies Coordinator, Senior with over 10 years of experience in managing clinical research studies, screening patients, conducting the informed consent process and enrolls patients on protocol.

Education:

Master of Science in Biochemistry,

Bachelor of Science in Chemistry & Biology

Key Databases:

Cerner Electronic Data capture for Registries and Clinical trialsPPD Clinical trial management System

InformeTrials EDC (Merge Healthcare)

Clintrial IDiary

Awarded for outstanding performance for Best Clinical Research Coordinator. Adept in conducting clinical trials, maintaining IRB compliance, according to

GCP guidelines.d Consistent history of providing quality service to patients to ensure high study

retention rates.

AREAS OF EXCELLENCE

Study Management Patient Recruitment & Assessments

Report Generation

Research & Analysis Specimen Collections Screening & Enrolling Data Analysis Excellent communication skills Data Entry in EDC like Cerner, Inf

PROFESSIONAL EXPERIENCESenior, Clinical Studies Coordinator, MD Anderson Cancer Center

February 2011 – Present Key Clinical Trials:• A Prospective Observational Study of Urinary Biomarkers of Nephrotoxicity in Cancer Patients Receiving Cisplatin Chemotherapy.

• A Randomized, double Blind, Placebo controlled Trial of Tolvaptan in Hyponatremic patients with cancer

• Solely responsible for management of clinical trials. Managed five interns. Study startup, initiation. Conducts research protocol operations and perform

protocol specific tasks including screening patients, and enrolls eligible patients into clinical trials, ordering tests, specimen collection, dispense investigational drug and provide patient teaching regarding adminstration of the drug. Maintains drug accountability, managing study visits and patient records. Accurate and timely collection of the data, documentation, entry and reporting. Schedules and participates in monitoring visits

Supervised trained and guided GRA’s, Research Interns and Research data coordinators in conducting clinical trials, data extraction, data entry and analysis and research study source documents etc.

Assist in the collection and evaluation of data for abstracts, research reports, funding proposals, operations and procedures manuals, and protocol specific documentation as needed.

Conduct internal random audits and assist with audit preparation. Serves as a backup resource to the regulatory team, provides support for labor-intensive

protocols as needed and assists in the preparation of annual reports or continuing reviews. In collaboration with the regulatory personnel, principal investigator, research nurses, and data coordinators, assists with maintaining a processing and tracking system for all protocol related paperwork.

• Assists in updating various database systems by adding new records or entering data• Attend internal/external educational conferences relating to clinical research education.

Clinical Research Coordinator, Senior, Baylor College of Medicine January 2003 – August 2010 Key Clinical Trials: National VA Amyotrophic Lateral Sclerosis research consortium (safety and dose escalating study of oral sodium phenyl butyrate in subjects with Amyotrophic Lateral Sclerosis)

Suppression of Myasthenia Gravis by targeting disease associated MHC, a biomarker study Altered Calcium regulation in moto neuron disease 2003-2005 Animal model biomarker study.

Managed over 20 clinical trials, responsible for screening and enrolling study participants, conducting study visits, coordinating follow-up visits, patient assessments, and dispensing medications. Documenting adverse events and serious adverse events

Maintained regulatory binders for IRB reporting and correspondence. Prepared for all site monitoring visits, drafted protocols for IRB approvals, and managed patient databases, and all aspects of clinical trials.

Worked closely with principal investigator to ensure compliance and patient safety.

Worked as part of a team with monitors and study sponsors to complete and ensure accurate case report forms and regulatory documents.

Built and established personal relationships with study participants to sustain high retention rates.

Managed two interns

Previous Experience

Senior Research Coordinator, Baylor College of Medicine (2003-2010)

Key Clinical Trials:A multi-center, double blind, randomized, placebo controlled, multiple dose, parallel design, dose ranging study of the safety and efficacy of AGN 203818IN. Sponsored by ALLERGAN

A multicenter, open label follow on trial to assess the long term safety and efficacy of Lacosamide in subjects with painful distal diabetic neuropathy.

Senior Research Coordinator, Michael E. Debakey VA Medical Center (2003-2010)Key Clinical Trials:

Prospective, randomized controlled third party blinded multicenter evaluation of Strattice TM/LTM in the repair of Inguinal (Ring) hernias.

A multicenter prospective, observational evaluation of repair of infected or contaminated Hernias (Rich) using LTM

Quality of life outcomes in Neurological disorders

Research Coordinator, Baylor College of Medicine (2001-2003)

Key Clinical Trials:A multicenter, randomized, double blind, parallel arm 6 week study to evaluate the efficacy and safety of Ezetimibe/Simvastatin versus Atorvastatin in patients with metabolic syndrome and hypercholesterolemia at moderately high and at high risk for coronary heart disease (MK-0653A Protocol 107)

Evaluation of Choline Fenofibrate (ABT-335) on carotid Intima-Media thickness (cIMT) in subjects with Type IIa and IIb Dyslipidemia with residual risk in addition to Atorvastatin therapy.

Research Assistant, Baylor College of Medicine (1999-2001)Worked on neuro-epithelial interactions, asses the growth and migration of regulatory molecules in affecting neuro-epithelial interactions in mouse dorsal root ganglia and human prostate carcinoma model.

PROFESSIONAL DEVELOPMENT

Training:• Informed Consent process, training at M. D. Anderson February 2013 Adverse Event Reporting, training at M. D. Anderson June 2014 •Human Subjects Research Training, 2011; •Clinical Coordinator Workshop, 2009; Comprehensive Clinical Research Coordinator, 2009; •Medical Terminology and Anatomy Physiology, 2002 Research Coordinator, 2006

Publications:

A randomized double-blind placebo controlled trial of tolvaptan in hospitalized cancer patients with hyponatremia

Abdulla Salahudeen, Najeeba Ali, Shana PallaNephrology Section, Department of General Internal Medicine, Department of Biostatistics, UT MD Anderson CC, Houston, TX(Submitted to NEJM on Feb 2013)

“Estrogen receptor beta expression in invasive breast cancer.” Journal Name, Volume #: Page# - Page#, 2002.Sherri Mann MD , Rodolfo Laucirica MD , Nicole Carlson , Pamela S. Younes BS, MHS , Najeeba Ali MS , Anas Younes MD , Yang Li and Mamoun Younes MD

“Over expression of the neutral amino acid transporter ASCT2 in human colorectal adenocarcinoma.” Journal Name, Volume #: Page# - Page#, Year.Witte D., Ali, N., Carlson, N., Younes, M.

Neuroepithelial interactions in prostate cancer are enhanced in the presence of prostatic stroma.Robert J Cornell; David Rowley; Thomas Wheeler; Najeeba Ali; Gustavo Ayala

Phase 2 study of sodium phenyl butyrate in ALS.Cudkowicz ME, Andres PL, Macdonald SA, Bedlack RS, Choudry R, Brown RH Jr, Zhang H, Schoenfeld DA, Shefner J, Matson S, Matson WR, Ferrante RJ; Northeast ALS and National VA ALS Research Consortiums.Amyotrophic Lateral Scler. 2009 Apr;10(2):99-106. doi: 10.1080/17482960802320487.PMID: 18688762 [PubMed - indexed for MEDLINE]

Related citations

Neuro epithelial interactions in prostate cancer are enhanced in the presence of prostatic stroma.Cornell RJ, Rowley D, Wheeler T, Ali N, Ayala G.Urology. 2003 Apr;61(4):870-5.PMID: 12670591 [PubMed - indexed for MEDLINE] Related citations

Expression of the vascular endothelial growth factor receptor-3 (VEGFR-3) and its ligand VEGF-C in human colorectal adenocarcinoma.Witte D, Thomas A, Ali N, Carlson N, Younes M.Anticancer Res. 2002 May-Jun;22(3):1463-6.PMID: 12168824 [PubMed - indexed for MEDLINE]

Overexpression of the neutral amino acid transporter ASCT2 in human colorectal adenocarcinoma.Witte D, Ali N, Carlson N, Younes M.Anticancer Res. 2002 Sep-Oct;22(5):2555-7.PMID: 12529963 [PubMed - indexed for MEDLINE] Related citations

Expression of the vascular endothelial growth factor receptor-3 (VEGFR-3) and its ligand VEGF-C in human colorectal adenocarcinoma.Witte D, Thomas A, Ali N, Carlson N, Younes M.Anticancer Res. 2002 May-Jun;22(3):1463-6.PMID: 12168824 [PubMed - indexed for MEDLINE] Related citations

Abstracts: Presented at Division of Internal Medicine 2012 Research Retreat:

“A Randomized, Double blind, Placebo controlled Trial of Tolvaptan in Cancer Patients with Hyponatremia (MD Anderson Hyponatremia Trial)” 2012Najeeba Ali, Shana Palla, Marina George, Amit Lahoti, Abdulla Salahudeen,

Medical Issues in cancer patients and survivors February 15-16, 2013“A Randomized, Double blind, Placebo controlled Trial of Tolvaptan in Cancer Patients with Hyponatremia (MD Anderson Hyponatremia Trial)” 2011Najeeba Ali, Shana Palla, Marina George, Amit Lahoti, Abdulla Salahudeen,

Will be presented at Southern Regional Meeting Feb 21-23 2013: “A Randomized, Double blind, Placebo controlled Trial of Tolvaptan in Cancer Patients with Hyponatremia (MD Anderson Hyponatremia Trial)” 2011Najeeba Ali, Shana Palla, Marina George, Amit Lahoti, Abdulla Salahudeen

Presented at the United States and Canadian Academy of Pathologists, Chicago, 2002:

Bystin, Trophinin & Tastin complex in Prostate Cancer Perineural Invasion Najeeba Ali, R. J. Cornell, Gustavo Ayala. Modern Pathology, 15 (1) 630 Jan 2002.

Stromal Ant apoptotic paracrine loop in Prostatic Carcinoma (Pca) Perineural Invasion Gustavo Ayala, T. Timme, Najeeba Ali, R. J. Cornell, T. M. Wheeler & T. Thompson

Perineural Ant apoptotic Mechanisms – The Cancer Loop Gustavo Ayala, T. M. Wheeler, Najeeba Ali, T. Thomson & M. Ittmann

Neuro -epithelial interactions in prostate cancer are enhanced in the presence of prostatic stroma. R. J. Cornell, Najeeba Ali, Gustavo Ayala

Presented at American Society of Dermato pathologists in Baltimore October 2000: “Expression of Protein Kinase C –B is down regulated or lost in the dermal component of melanocytic neoplasm’s.” Reed Jon, Najeeba Ali, Albino A. P. American Journal of Pathology