Reema Singh

Freelance Researcher & Transcriptionist

1607
Location:Oceanside, California, United States
Profile:https://www.freelanced.com/reemasingh
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Reema Singh

reemasingh79@yahoo.com • 310-739-3058

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 – 04/2011 Clinical Research Coordinator
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 – 04/2010 Clinical Research Coordinator
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;
• Organized preceptorship meetings educating phamaceutical companies/CROs regarding how best to treat patients with COPD and asthma;
• 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;
• Created brochures/flyers, placed print/radio ads, obtained targeted mailing lists and gave presentations to local area schools regarding trials;
• 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 ****** 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 ****** Medicine
• HIV
• Oncology
• Pathology
• Pediatric Pain
• Pediatric / Orthodontic Dentistry
• Radiology
• Respiratory (Asthma / COPD)
• Women’s Health

LANGUAGES:

• Proficient in Spanish, Hindi and Urdu.
Skills (2) Rating
Research
Transcription