Medical Clinical Research

SAMINA B HABIBI M.B.B.S, M.S

Home Address: *** ******* *****

Indiana, PA 15701

Phone: 724-***-****

E-mail: ************@*****.***

Cell Phone#: 928-***-****

WORK EXPERIENCE

Remote Medical Analyst-PRN Litigation Management Inc.

(11/2014-present)

Provide analyses of medical information for the defense of claims where health, illness or injury is an issue.

Assists in delivery of customized work products to meet needs of client.

Clinical Research Coordinator Ilumina Clinical Associates

(10/2009-8/2015)

Implement clinical research and insure compliance with clinical protocols, institutional

Regulations and FDA requirements

Independently prepares required regulatory documents for submission of new protocols

Comprehensive review of medical records both paper and electronic charts to find eligible patients for the clinical trial

Actively involved in negotiating the contract and budget with the sponsor per site requirement

Responsible to develop collaborative relationships with area physicians and site staff to conduct feasibility assessments.

Develops investigator lists according to their research interests, to ensure the site list is reflective of the defined site profile for each trial.

Conducts face to face meetings with the area physicians and their staff to discuss standard care and obtain protocol-level input to support trial optimization projects.

Conducts all aspects of clinical trial management including recruitment and screening of the potential study subjects according to the protocol’s inclusion and exclusion criteria, obtain written informed consent from each study subject prior to participation, schedule study visits and define the study visit activities completely and accurately. Ensure quality health care through careful monitoring of all patients and procedures.

Report all adverse events and serious or unexpected adverse events to the investigator and reporting to the sponsor and IRB as required by protocol and regulation.

Design and maintain organizational tools that will aid in the conduct of the study for data collection. Maintain adequate source documentation for easy verification of reported data in CRF. Complete case report forms (hard copy or electronic) accurately and completely. Reconcile any discrepancies and AE/SAE reporting in timely manner

Communicate with sponsor to discuss the conduct of the study and review study data in association with or as directed by the Investigator. Preparation for site visits by collecting and organizing all clinical sources of subject data pertinent to clinical trial. Involve in dealing with monitoring of site selection and site initiation visits.

Act as liaison between patients, investigator, and other site personnel to ensure continued patient participation and safety in the studies. Educate other medical staff and site personnel in understanding and implementing protocol.

Temporary Faculty Indiana University of Pennsylvania

Biology Department (08/2008 to 05/2009)

Taught courses in:

General Biology

Lab courses in Microbiology and Human Anatomy

Associate Faculty Mohave Community College, Bullhead City, AZ

(01/2005 – 05/2008)

Taught courses in:

Allied Anatomy and Physiology

Anatomy and Physiology (both lecture and lab)

Medical Ethics and Law

Microbiology (both lecture and lab)

EDUCATION

Postgraduation M.S in Clinical Lab Sciences (08/2003)

University of Wisconsin- Milwaukee

Graduate GPA 3.82

(Human Pathophysiology, Molecular Pathology, Public Health

Microbiology, Medical Lab Mgmt&Education, Genetics)

Certification Molecular Diagnostics (09/2003)

University of Wisconsin-Milwaukee

College of Health Sciences

College and M.B;B.S (06/92)

Medical School: University of Karachi, Sindh Medical College

Karachi, Pakistan.

POSTGRADUATE TRAINING

Internship and House Physician

Residency: Department of Medicine (07/92 - 12/93)

Department of Dermatology (12/93 - 06/94)

Sindh Medical College, Karachi, Pakistan

ACADEMIC HONOURS, AWARDS

Recipient of Scientific Research Symposium Award (1st place) in Clinical Laboratory Sciences for poster presentation

RESEARCH EXPERIENCE

Primary Coordinator in a Phase IV, Multicenter, Double-Blind, randomized,

Placebo –controlled Study of the Safety and Tolerance of Investigational Drug in

Subjects with Renal Impairment, 2009

Primary Coordinator in a Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in

Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome, 2010 (EXAMINE)

Primary Coordinator in a Phase III, Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter, Multi-national study for the Evaluation of Efficacy and Safety of an Investigational Drug versus Warfarin in Subjects with Atrial Fibrillation, 2010

Primary Coordinator in a Multicentre, Randomized, Double –Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Investigational Drug on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes,, 2010

Primary Coordinator in a Phase III, Multicentre, international, randomized, parallel group, double blind cardiovascular safety study of Investigational Drug administered compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular, 2011

Primary Coordinator in a Phase IV, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared with Mitomycin C in the Intravesical Treatment of Subjects with BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer, 2011

Primary Coordinator in a Multicentre, Randomized, Double –Blind, Placebo-Controlled Trial to Evaluate the Effect of Investigational Drug on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes, 2013

Primary Coordinator in a Clinical Outcomes Study to Evaluate the Effects of IL-6

Receptor Blockade with Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on

the rate of Ischemic Cardiovascular Events in Patients With Moderate to Severe

Rheumatoid Arthritis (RA), 2012

Primary Coordinator in a Phase 3 Randomized, Double-Blind, Multicenter, Placebo-

Controlled Study to Assess the Efficacy and Safety of Lesinurad Monotherapy Compared

to placebo in Subjects With Gout and an Intolerance or Contraindication to a Xanthine

Oxidase Inhibitor, 2012

THESIS

Relationship between Genomic Instability and Environmental Factors in

Invasive Breast Cancer (08/16/2003)

CORE COMPETENCES

• Friendly, outgoing, easily adapts to new environment, working cooperatively with peers

and medical staff. Exhibiting confidentiality, flexibility, and accountability

• Exemplary office management skills, electronic filling, and electronic record keeping.

• Exceptional organizational / planning skills simultaneously managed and monitored

multiple tasks

• Outstanding leadership, conflict / dispute resolution, communication, and interpersonal

skills; interface effectively with employees and patients/clients of diverse socioeconomic

backgrounds and cultures; quickly resolves problems/conflicts in professional manner.

Team and results oriented.

• In depth knowledge of medical causation and medical standard of treatment.

• Strong verbal and written communication skills.

• Profound ability to manage multiple tasks and deadlines simultaneously

• Ability to learn new procedures and material quickly; superior memory and attention to

details

• Proficient in MS Word, Excel, and Power point, and MS Outlook

Contact this candidate