Clinical Research Associate


Last Updated: 23rd October 2017 (over 5 years ago)

Address
United Arab Emirates

E-mail
Locked

Gender
Female

Age Range
25 to 34

Qualification Level
Degree

Languages
English

Summary

I currently conduct monitoring activities such as confirming the accuracy and integrity of data, resolving queries, and reviewing protocol deviations and serious adverse events. I also ensure compliance with all protocol procedures by reviewing monitoring reports and supporting ongoing site and CRA training. I maintain study metrics on core lab data, site start-up activities, enrollment, and data collection. I also confirm electronic master files include all required documentation for start-up, IMP release, and ongoing audit readiness.

Education


SOCRA Certified Clinical Research Coordinator

   Aug 2012

The Society of Clinical Research Associates (SOCRA) has developed an International Certification Program in order to create an internationally-accepted standard of knowledge, education, and experience by which CRPs will be recognized as Certified Clinical Research Professionals (CCRP®s) in the clinical research community. The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials.
(http://www.socra.org/certification/certification-program-overview/introduction/)

University of San Diego
Bachelors degree

   Aug 2002
— May 2006

BA in Psychology and English, Honors program, summa cum laude

Experience

ARCA biopharma, Inc.
Clinical Research Associate

   Apr 2016
— Current

 Ensure staff compliance with study objectives, ICH-GCP, global SOPs and regulatory obligations, and identify issues in accordance with project plans
 Evaluate integrity of clinical data and appropriate follow-up procedures with remote source data verification, query resolution, SAE review, and collection of documents for clinical events committee
 Manage clinical study sites with ongoing site training, day-to-day support, and co-monitoring visits
 Track and maintain study metrics, progress, and key study parameters and provide routine study updates on items such as start-up activities, enrollment, site management, data collection, data reviews, site feasibility, and database lock
 Create, revise and review clinical trial materials such as informed consent forms, case report forms, study specific tools, manuals, monitoring plans, and departmental SOPs to ensure timeliness, standardization and control of data quality
 Participate in the analysis and reporting of safety issues, patient care issues, study design and/or study conduct issues
 Manage internal trial master files to confirm accuracy of investigator site files and prepare for audit readiness
 Assist with evaluating and selecting study sites and review of regulatory document and clinical trial application documents

University of Colorado, Division of Cardiology
Clinical Research Coordinator

   Oct 2015
— Apr 2016

Research coordinator for industry and investigator-initiated trials within interventional cardiology, electrophysiology, heart failure, genetics, and cardiology imaging
 Monitored and ensured compliance of participants, including entry of required follow-up orders, scheduling appointments, and completion of required interviews and evaluations
 Documented and maintained study records, including lab test results, procedures, and visit records on paper and in a wide variety of electronic data entry systems
 Developed and submitted IRB and other regulatory submissions, including initial applications, consent forms, continuing review reports, amendments, and unanticipated problem reports with local and national IRBs
 Maintained sponsor-specific subject and regulatory files with documents from start-up to study completion
 Assisted with the drafting of protocols, consent forms, case report forms, and other required documents for investigator-initiated trials
 Evaluated eligibility and recruit potential subjects with EPIC electronic medical records
 Trained new personnel on research coordinator duties, GCP, and UCD policies
 Assisted the divisional clinical trials manager with hospital reimbursement and budget development for upcoming clinical trials and coordination of research subject payment

University of Colorado, Barbara Davis Center
Clinic Team

   Jun 2009
— Sep 2010

 Enrolled and obtained consent, HIPAA, and interviews for participants and/or parents for pediatric studies of the development of type 1 diabetes
 Collected samples including phlebotomy, saliva, viral swabs, height, and weight
 Scheduled on-site clinic visits and coordinated office visits

University of Colorado, Project Safe
Interviewer

   Oct 2007
— May 2009

 Screened, obtained informed consent and HIPAA, and interviewed participants for various studies of illicit drug users and infectious disease
 Created standardized interviews for an audio-assisted computer interview program
 Completed entry, verification, tracking, and reporting of data
 Prepared initial and continuing reviews and protocol amendments for IRB review

Institute of Behavioral Sciences, University of Colorado
Professional Research Assistant

   Aug 2006
— Sep 2007

San Diego Study of Domestic Violence
 Completed coding, data entry, and statistical analyses with SPSS and Access
 Prepared tables and presentations for final reports using Microsoft Office suite

Institute of Behavioral Genetics, University of Colorado
Research Assistant

   May 2005
— Aug 2006

Longitudinal Twin Study of Reading Development
 Administered, scored, and entered data for various tests of reading to twin pairs

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