Manager Assistant

TINA RUTH GONSALVES

***, **** ******, ********, ** 11209

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

Cell: 347-***-****

OBJECTIVE

To participate in a Research Team that is devoted to finding better diagnosis, treatment and

prediction of different complex diseases while trying to expand my knowledge, skills in diagnostic

and clinical research and confidently motivating colleagues to meet the high performance standards

required for a sound study.

SKILLS

• Goal-driven leader with a detailed knowledge of monitoring study procedures for different

types of diseases.

• Comprehensive knowledge of GCP and ICH guidelines, reviewing S.O.P’s for site

monitoring, maintaining Trial Master Files and regulatory requirements for clinical trial

processes.

• Exceptional communicator who effectively conveys information verbally and in writing.

• Flexible team player that thrives in environments requiring ability to prioritize and multiple

concurrent projects.

• Proficient in computer software applications such as, Microsoft Office, SAS and SPSS.

EDUCATION

New York University College of Dentistry, NY May 2010

Master’s Degree in Clinical Research

Courses taken:

• Scientific writing: Protocols & Grants, Literature Review of clinical studies.

• Fundamentals of Data Management, Bioethical Issues & IRB skill, Biostatistics.

Ramaiah Dental College, Bangalore, India June 1998- March 2004

Bachelor of Dental Surgery

Khalsa College, Mumbai, India June 1996- March 1998

WORK EXPERIENCE

Clinical Research Coordinator, Staten Island University Hospital, NY March 2013- August 2013

• Recruited subjects for studies in the Pediatric Department at Staten Island University

Hospital, NY.

• Educated Research Team and Department on the protocol requirements, FDA Regulations,

GCP and ICH guidelines, reviewing S.O.P’s for site monitoring, informed consent process,

study design, protocol preparation, and requirements of Trial Master Files.

• Assisted in preparing protocol, IRB applications, FDA –required regulatory submissions and

Case Report Forms.

• Acted as liaison between the investigative sites, Principal Investigator, the IRB and the

sponsor.

• Coordinated and planned investigator meetings and research committee meetings with Study

Team and Pediatric Department.

• Assisted with study start-up, maintenance, closeout of study and query resolution for studies.

• Collected, tracked and reviewed FDA-required regulatory documents for accuracy.

• Obtained experience in Oncology studies-Phase II Langerhans cell Histiocytosis by GSK and

Phase III Trial Double Blind, Placebo-Controlled, Multicenter Trial in sickle cell disease.

• Created, maintained and performed audits on research data, patient records, Trial Master

files, S.O.P’s, source documents and other regulatory documents.

• Worked with Pediatrics residents on the regulatory and IRB application process, observed

informed consent process, studied assessments and updated prescreening log while reviewing

documents for accuracy of data.

• Coordinated research committee meetings for the Pediatric department.

• Prepared budgets for the studies and requested reimbursement of site personnel expenses.

• Responded to all inquiries or concerns coming from team members in a timely fashion.

• Communicated regular updates / reports of performed duties regularly to team members.

• Read and responded diligently to internal and external correspondence.

Regulatory Coordinator, part –time volunteer, Beth Israel Cancer Center, NY January 2013

• Prepared IRB applications, FDA- required regulatory documentation to IRB and Case Report

Forms.

• Worked with other research coordinators to review regulatory binders, audit regulatory

documentations and update regulatory logs.

Research Development Specialist, Soma International LLC, NY October 2012 – March 2013

• Tested OTC products to fulfill the company’s marketing requirements by performing protocol

and testing the authenticity of the brands of products.

• Read and responded diligently to internal and external correspondence.

• Recommended new products or marketable items to the company as a result of research and

development work.

• Collected, recorded and entered data into the database.

• Reviewed documents for accuracy of data, filed and maintained documents, logs and

prepared reports.

• Ensured all outgoing products were examined and inspected before they were delivered.

Research Coordinator, NYU, NY June 2010 - December 2010

• Recruited subjects for Foregut Microbiome Study in development of Esophageal

Adenocarcinoma at Bellevue, VA hospital.

• Collected, recorded and entered study data into the database.

• Obtained informed consent and educated participants regarding the study.

• Assisted in screening participants for eligibility, prepared grant applications, IRB/GCO for

submission and maintained source documents, Case Report Forms and subjects’ files.

• Maintained Trial Master Files and reviewed S.O.P’s and ICF for accuracy and completeness.

Research Intern, NYU Bluestone Centre, NY September 2009 – May 2010

• Prepared protocol, IRB application and Case Report Forms.

• Performed audits on research data, patient records and regulatory documents.

• Worked with other research coordinators on a phase II study, observed informed consent

process, studied assessments, reviewed regulatory binders, and updated prescreening logs.

• Supported site audits, maintained Trial Master Files and assisted in all audit preparation

activities.

• Interacted with sites, clinical team, CRAs and other study team personnel to resolve issues

with study documents including missing, incomplete and/or misfiled documents.

• Reviewed site ICF amendments for administrative modification.

• Updated and prepared reports for all departments with information received.

Laboratory Assistant NYU Department of Basic Science March 2008 - November 2008

• Collected and tested spore samples.

• Labeled and prepared of spore sample records.

Office Assistant, NYU Department of epidemiology October 2007

• Organized and coordinated with the Research Department.

• Assisted in office related duties.

Manager, Refrigeration World, Doha Qatar May 2005 – December 2006

• Managed the company’ contracts and finances.

• Supervised the company' staff's payroll, schedules and meeting.

• Developed vital management and interpersonal skills while employed with the company.

Dentist, M.S. Ramaiah Dental College, Bangalore, India April 2004 - April 2005

• Worked as a dentist treating low-income patients with medical/dental problems.

• Counseled and managed cases for patients with oral cancer and other diseases.

• Collected information on patients’ oral health and provided oral health education to adults

and underprivileged children.

• Participated in various workshops including Management of Difficult Children and Genetics

of the Future.

ACTIVITIES

• Certificate of completion for “Bridging the Gap” course at Cross Cultural Health Care at

Weill–Cornell Medical College, Doha Qatar.

• Volunteered at health camps in schools and underprivileged areas in Bangalore, India.

• Volunteered at St. Theresa’s Home for AIDS patients, New York.

• Member of the Young Adult group of St. Patrick’s Cathedral, New York.

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