Reema Singh

abgz0o@r.postjobfree.com . 310-***-****

SUMMARY:

Clinical research professional with extensive knowledge of clinical trial

operations and web-based data collection systems. Experience includes study

coordinating both NIH and drug sponsored, longitudinal/short-term trials,

wet-bench lab technique, data collection/management, patient

recruitment/retention skills and obtaining patient consent/administering HIPAA.

Sound familiarity with clinical study monitoring, medical terminology, FDA, ICH

and GCP regulations. Strong ability to work and communicate with medical

professionals. Highly ambitious, with excellent interpersonal and

communications skills. Extremely organized and detail-oriented.

PROFESSIONAL EXPERIENCE:

08/2010 - Clinical Research Coordinator

04/2011

Vista Medical Partners Beverly Hills, CA

Responsible for coordinating research/recruitment operations in

HIV;

Prepare/complete clinical trials regulatory documents, case

report forms, data correction forms (DCF), serious adverse

events and grant/IRB documentation;

Attend off-site clinical meetings, i.e. investigator's

meetings;

Networking with study participants, clinical sponsors and

health professionals

Follow-up and screen lab reports;

Obtain informed consent and HIPAA from participants;

Order supplies and services;

Review and request subject medical records;

12/2008 - Clinical Research Coordinator

04/2010

North County Radiology Oceanside, CA

Responsible for coordinating research/clinical operations in

radiology;

Prepare/complete clinical trials regulatory documents, case

report forms, data correction forms (DCF), and grant/IRB

documentation;

Attend off-site clinical meetings, i.e. investigator's

meetings;

Manage research databases for data collection;

Networking with study participants, clinical sponsors and

health professionals

Follow-up and screen lab reports;

Obtain informed consent and HIPAA from participants;

Oversee recruitment activities;

Confirm appointments of study participants;

Prepare lab for participant visits;

Order supplies and services;

Transport research specimens between various labs;

Review and request subject medical records;

Complete serious adverse events; IRB reports/submissions;

3/2007 - 10/2008 Clinical Data Coordinator

Synteract, Inc. Carlsbad, CA

Ensures all issues relative to the clinical database are

addressed with the appropriate personnel;

Review/validates database records/live study data entered by

Data Processing;

Writes, resolves and modifies data discrepancies/queries;

generates, formats and edits data discrepancy reports to sites,

sponsor, or Clinical Research Associates; communicates as

necessary to help resolve queries and data/database issues, and

other sponsor requests during course of study;

Updates and/or reviews changes to the clinical database

following the query and resolution process;

Produces reports, listings, and other as required during the

course of the study.

Exports data form the clinical database to update the SAS

database;

Creates/directs the creation of patient profiles to check all

data points;

Creates and maintains Study Binder and/or study-specific files;

Coordinates the final QC process at the close of the study

Performs final quality control check of profiled clinical data;

Provide training and guidance to other Data Management

personnel;

Assists in the development of Case Report Forms (CRFs) for data

collection;

Performs quality control tests prior to entry of live data by

creating/entering test data into the clinical database,

collecting and reviewing the output/export;

10/2003 - 2/2007 Staff Research Associate/Study Coordinator/Data Manager

David Geffen School of Medicine at UCLA, Department of

Pulmonary and Critical Care Los Angeles, CA

Responsible for data collection in clinical trials of patients

with chronic obstructive pulmonary disease (COPD);

Prepare/complete clinical trials regulatory documents, case

report forms, data correction forms (DCF), and grant/IRB

documentation;

Attend off-site clinical meetings, i.e. investigator's

meetings;

Manage research databases for data collection (FileMaker Pro,

Microsoft Excel);

Networking with study participants, drug sponsors and health

professionals

Coordinate and work closely with clinical trials' monitor

Follow-up and screen lab reports;

Obtain informed consent and HIPAA from participants;

Assist lab technicians with procedures (i.e., phlebotomy,

spirometry, infusions, and general lab procedures);

Oversee recruitment activities;

Conduct non-pulmonary function test (PFT) visits;

Collect, count and dispense study drug;

Confirm appointments of study participants;

Prepare lab for participant visits;

Order supplies and services;

Transport research specimens between various labs;

Manage dispersal of subject fee payments, parking passes and

meal tickets;

Review and request subject medical records;

Complete serious adverse events.

1/2000 - 9/2003 Staff Research Associate/Study Coordinator/Data Manager

Mattel Children's Hospital at UCLA, Department of Pediatric

Pain, Los Angeles, CA

Joined as student clerk, quickly promoted to staff research

associate;

Responsible for carrying two landmark studies, NCI-funded

Childhood Cancer Survivor Study and NIH-sponsored Puberty and

Gender Study with participants 8-17 years;

Collected physiological data including blood and saliva

samples, blood pressure, heart rate and ECG using computer and

various physiological instrumentation;

Administered laboratory stressor tasks and psychosocial

measures;

Recruitment/retention of participants;

Obtained informed consent/HIPAA from study participants

Responsible for IRB reports/submissions;

Conducted follow-up patient phone calls and visits;

Scored/coded self-reported psychosocial questionnaires using

SPSS, Microsoft Access and Excel computer software programs;

Literature searches; gathering references.

7/2001 - 10/2001 Research Assistant

Female Sexual Medicine Center at UCLA, Department of Urology,

Los Angeles, CA

Prepared patient charts/records; maintain study binders

Transcribed source documents to CRF's

Prepared documents for studies / grants

Performed basic laboratory tasks

6/2000 - 6/2001 Laboratory Technician

University of California, Los Angeles, Department of Chemistry

and Biochemistry, Los Angeles, CA

Autoclaving

Crystallizations

Titrations

Distillations

Pipetting

Maintaining lab

Ordering supplies

6/1999 - 10/1999 Internship

Applied Materials, Santa Clara, CA

Created and maintained databases;

Edited / composed staff training manuals for new computer

software;

Performing background checks on potential new hires,

recruitment of new hires;

Utilized programs such as Demand Planner, Oracle, and Microsoft

Office.

9/1997 - 6/1998 Office Assistant

UCLA School of Dentistry, Department of Pediatric/Orthodontics,

Los Angeles, CA

Data entry

Grading/scoring exams

Prepare dental projects

Composed student portfolios

Daily office tasks and lab maintenance

EDUCATION:

University of California, Los Angeles, California

Bachelor of Science, Organismic Biology, Ecology and Evolution - 2001

Pertinent COURSES:

IRB Submissions Workshop 12/15/04

Biomedical and Genetics Research, 05/14/05

HIPAA Privacy Rule Research Education Course, 05/14/05

HIPAA Security Training, 05/14/05

CPR and First Aid Training, 08/25/05

Clinical Research the Basics, 11/18/05

Advocacy & the Informed Consent Process, 02/09/06

GCPs: Source Documentation & Data Management, 02/23/06

Clinical Trials Budget Workshop, 04/27/06

FileMaker Pro, 07/11/06

* all obtained at UCLA

LICENSURE/CERTIFICATIONS/MEMBERSHIPS/PUBLICATIONS:

. Cambridge Who's Who Member, April 2009

. Certificate of Completion, Protecting Human Subject Research

Participants, Awarded April 27 2009, The National Institute of Health

(NIH) Office of Extramural Research

. Basic Life Support for the Healthcare Providers, Awarded April 04, 2009,

American AED / CPR Association

. Certificate in Winning Project Management, Awarded May 17, 2008, Career

Builder Institute

. Certificate of Completion, Ethics in Patient Oriented Research, Awarded

Fall 2005, UCLA

. Certificate in Medical Waste Management, 09/07/05, UCLA

. CPR and First Aid Training, 08/25/05

. Vice Provost Recognition Award 2000 - 2001 for Community Outreach and

Education in CityLab UCLA

. Vice Provost Recognition Award 1999 - 2000 for Community Outreach and

Education in CityLab UCLA

Pertinent Clinical Trials Skills:

Strong computer skills including all MS Office programs (i.e., Outlook,

PowerPoint, Word and MS Project); proficient with both Mac and PC platforms.

Extensive computer database management skills including Microsoft Access,

Microsoft Excel, FileMaker Pro; statistical coding / data entry programs SAS

and SPSS; Oracle Client.

Trained in IVRS, IWRS and electronic data capture (EDC) including OmniComm,

Perceptive, PhaseForward, Remote Data Capture (BIPI), ClinTrial and DataFax.

Excellent written and oral skills.

Extremely detail-oriented.

Sound experience with resource and budget / financial managements.

Strong knowledge of clinical study guidelines including FDA, ICH & GCP.

Highly proficient in study start up work, i.e., networking with in-house staff,

conducting study initiation visits and compilation / maintenance of all

regulatory documents.

Strong interpersonal communication skills; aggressive at forming new

relationships and excels at patient recruitment / retention.

Therapeutic Areas of Expertise:

I have managed or worked on both NIH and industry sponsored trials from Phase 1

to Phase IV that are multi-center and longitudinal in the following therapeutic

areas:

Biochemistry

Female Sexual Medicine

HIV

Oncology

Pathology

Pediatric Pain

Pediatric / Orthodontic Dentistry

Radiology

Respiratory (Asthma / COPD)

Women's Health

LANGUAGES:

Proficient in Spanish, Hindi and Urdu.

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