Medical Data Entry

OBJECTIVE

I am a highly energetic foreign medical graduate with experience in clinical and academic settings. I have extensive experience in study initiation & planning activities, grant & protocol writing, patient recruitment, study visits, data entry, patient education, termination of study and preparation of final study report. I have independently interfaced with patients, worked with CRAs, helped in handling drug inventory, monitored adverse events and worked in solving data queries related to study. I have thorough understanding of clinical trial policies and regulations (ICH) and Good Clinical Practice (GCP) in my previous work positions in Oncology and Diabetes clinical trials. Have extensive understanding of FDA and IRB regulations and operations. Experience in investigator initiated as well as industry sponsored research. My key skills include very detail oriented, enthusiastic, team worker and able to lead. I have strong organizational skills with high degree of accuracy. I have strong technical, analytical, problem solving, communication and relationship management skills. I am a computer literate with good working experience of statistical tools and proficient with all Microsoft operating systems, MS office, SharePoint, Power Point and Adobe.

PROFESSIONAL EXPERIENCE

Seattle Cancer Care Alliance, Seattle, WA 2010-2011

University of Washington, Seattle, WA

Sr. Research Coordinator (Jan 2010 to May 2011)

Working for GU Oncology group for Dr Celestia Higano and Dr. Evan Yu

Prostate Cancer clinical trials (Phase I, II, III, some involving infusions)

Involved in complex decision making tasks like discussing the future treatment/ clinical trial options for castration resistant metastatic prostate cancer.

Involved in reporting of adverse events (AE and SAE) and documenting on case report forms.

Responsibilities:

• Development recruitment strategies and conducting screenings for study participants using electronic data.

• Screening, recruitment, enrollment and randomization of subjects for study

• Development of CRFs

• Obtaining informed consent, medical history, vital parameters, administering surveys, providing patient education, ordering study medications using IVRS, doing phlebotomy.

• Performed phlebotomy and obtained specimen for in vitro diagnostics.

• Performed common in vitro tests and handled, processed, shipped biological specimens.

• Ensured proper handling of research specimens.

• Electronic data entry in EDC data system and experience with IVRS

• Ensure compliance with research protocols, review case report forms and audits for accuracy with source documents, attend monitoring meetings with sponsors.

• Prepare regulatory submissions.

• Filling Case Report Forms, reporting AE’s and SAE’s.

• Implement protocol updates and manage deviations.

• Study meetings with Investigators and Monitors to ensure smooth flow of overall study.

Clinical trials: Oncology

• Kinex KX01-002-09: A Phase II, Open-Label, Single-Arm Study Evaluating the Safety, Efficacy and Pharmacokinetics of KX2-391 in Patients with Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Received Prior Chemotherapy

• Medivation Phase I: Phase I, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of MDV3100 in Patients with Castration-Resistant Prostate Cancer.

• AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy.

• OGX-427-01: A Phase 1 Study Evaluating A Second Generation Antisense Oligonucleotide (OGX-427) That Inhibits Heat Shock Protein 27 (Hsp27).

• Millennium: A Randomized Phase 2 Study of MLN8237, an Aurora A Kinase Inhibitor or No MLN8237 in Patients with Castration-Resistant Prostate Cancer Receiving A Standard Docetaxel/Prednisone Regimen, Preceded by a Phase 1 Dose-Escalation Study.

V A Medical Center, Atlanta, GA 2009

Emory University Hospital, Decatur, GA

Clinical Study Coordinator (April 2009 to Dec 2009)

Involved in multiple diabetic clinical research trials for Dr Lawrence Phillips.

CITI Certified – Emory University & Atlanta VA Hospital

V A Credentialized.

Clinical trials: Diabetes

• NN2211-1842: The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabtes. A 26 week, randomized, open label, parallel group, multicenter, multinational trial with a 26-week extension.

• BCB106: A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, & Tolerability of Exenatide Long-Acting Release to Those of Sitagliptin and Pioglitazone in Subjects with Type 2 Diabetes Mellitus Treated with Metformin.

• NN 1250-3579: A 52-week randomized, controlled, open label, multicenter, multinational treat-to-target trial comparing the efficacy and safety of SIBA and insulin glargine, both injected once daily in combination with oral anti-diabetic drugs ( OAD), in subjects with type 2 diabetes mellitus currently treated with OAD(s) and qualifying for more intensified treatment.

Responsibilities:

• Instrumental in writing protocol for Investigator initiated clinical studies.

• Screening, recruitment, enrollment and randomization of subjects for study

• Obtaining informed consent, medical history, vital parameters, administering surveys, providing patient education, ordering study medications using IVRS, doing phlebotomy.

• Developing CRFs

• Phlebotomy and obtaining specimens for in vitro diagnostics

• Performed basic lab tests and handled, processed, shipped biological specimens.

• Electronic data entry in EDC data system.

• Ensure compliance with research protocols, review case report forms and audits for accuracy with source documents, attend monitoring meetings with sponsors.

• Prepare regulatory submissions.

• Filling Case Report Forms, reporting AE’s and SAE’s.

• Implement protocol updates and manage deviations.

• Worked closely with Monitors to ensure the accuracy of study data.

University Of Cincinnati, OH 2006 - 2008

Study Coordinator/Research Assistant (Sep 2006 to Dec 2008)

Lipid Adipokine and Prenatal Programming (LAPP study)

• Assist in grant writing and protocol development.

• Created informed consent document, HIPPA privacy document, Physician order forms and Laboratory request forms.

• Created study packets.

• Created recruitment scripts and fliers.

• Developed recruitment strategies.

• Performed on site and telephone recruitment for the study.

• Recruited over 200 pregnant patients for the study.

• Screened the subjects and obtained consent from them following IRB and HIPPA guidelines.

• Monitored study visits at General Clinical Research Center of Cincinnati Children’s Hospital and obtained blood draw from the patients for serum analysis.

• Administered survey questionnaire.

• Obtained specimen for in vitro diagnostics

• Created Excel spreadsheets for all the data.

• Performed data analysis

Effect of Adiposity on Serum Leptin and Adiponectin levels (Masters Thesis Project)

• Recruited 75 pregnant women from University Hospital.

• Screened and obtained consent for the study.

• Performed anthropometric measurements of the patients

• Obtained blood draw on early pregnancy and late pregnancy visits and performed lab tests.

• Leptin and Adiponectin were measured by ELISA method.

• Performed Data analysis done with SPSS 14.0.

Ruby Hall Clinic, Pune, India 2003 – 2005

One of the best cardiology hospital in India.

Physician, Medical Officer, Coronary Care Unit and Neuro and Trauma Units (Apr 2003 to Nov 2005)

• Managed the treatment of critically ill patients in cardiac as well neurological section of intensive care unit with extensive monitoring and guidance from senior Cardiac specialists.

• Managed pre and after operative care of Coronary patients.

• Supported the cardiac rehabilitation program and was actively involved in patient education.

• Participated in clinical trial in cardiovascular medicine, for a drug used in patients with myocardial infarction.

• Involved in study planning activities, blood draw, administering the drugs, monitoring patients post drug administration, tracking of the patients, entering data, filling study documents, reporting adverse events, study termination activities.

Rural Training Center, Shirur, Pune, India 2001 - 2003

Physician, Medical Officer (Sep 2002 – Mar 2003)

Internist (Jul 2001 – Oct 2001)

• Provided health check up and treatment on health ailments in OPD (Out Patient Department)

• Handled emergencies: poisoning, snakebites, burns as well as Obstetrics unit

• Implemented National Immunization Schedule.

• Implemented Maternal Health and Child Nutrition initiative.

• Led Project on “Health Education in Adolescent population about Sex, Contraceptives, Sexually Transmitted Diseases, HIV and AIDS”. Presented it to the Department of Preventive and Social Medicine in my College, which was highly praised by faculties.

• Instrumental in raising funds and getting help from Rotary foundation for expensive medications to needy individuals

Dr B. A. Ambedkar Cantonment Hospital, Kirkee, Pune, India 2001 – 2002

Internist (Oct 2001 to July 2002)

• Provided direct care to patients with various ailments, served the departments of Medicine, Surgery, Gynecology, Opthalmology, Pediatrics etc.

• Implemented School Health Program in surrounding 16 primary schools offering health check up and brief survey assessing the health status and physical fitness of school students.

• Participated in Revised National Tuberculosis Control Program

• Cited by the Medical Officers as best Intern ever worked

EDUCATION

Masters in Nutritional Sciences, University of Cincinnati, OH, GPA-3.8, 2009

Clinical Research Professional Development Program, KRIGER Research Institute, 2009

Bachelor of Medicine and Bachelor of Surgery- Physician in India(MBBS). B.J. Medical College, Pune University, India, GPA-3.9, 2003

PROFESSIONAL AFFILIATIONS

Registered with Medical Council of India

Member of Nutrition Council Cincinnati

Member of Student dietetic Association

HONORS and AWARDS

Awarded “Certificate of Appreciation” while serving at Seattle Cancer Care Alliance for my outstanding dedication to work.

Awarded the “Best student Poster” award at poster presentation ceremony at University of Utah “Healthy people 2010: Childhood Obesity”.

Honored at the 4th Annual Grants Recognition and Reception event conducted by the Office of Sponsored Projects & Research at University of Cincinnati.

Awarded “Best Registrar” award in Intensive Care at Ruby Hall Clinic, India.

COMPUTERS

Microsoft Word, Excel, PowerPoint, Publisher, Access, Outlook, Adobe

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