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Clinical Research Training

Location:
United States
Posted:
August 28, 2012

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Resume:

Dara Dary, BS, CCRP

*** ****** ****** ****.

Gilberts, IL 60136

obrcwt@r.postjobfree.com

847-***-****

CAREER PROFILE

Over 12 years’ experience of detailed management skills both in Clinical Research projects and Institutional Review Board (IRB) office

Proven track records of strong and in-depth knowledge of IRB protocol requirements, Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) and Federal regulation guidelines.

Strong leadership skills and experience in coordination and collaboration with highly reputable hospitals, PIs (Principal Investigator) and healthcare departments in clinical research.

Demonstrated ability to successfully take on increased responsibilities, as well as, envision and articulate future direction. High degree of accuracy and attention to detail.

PROFESSIONAL WORK

EXPERIENCE

Central DuPage Hospital, Winfield, IL 2008 – Present

Research and IRB Educator (CCRP)

• Manage all IRB work and its related activities without current office director.

• Educate research staff and review all research study documentations.

• Monitor and adhere to rules and regulations within Central DuPage Hospital (CDH) system in strict compliance with the study protocols and all CDH policies, as well as, state and federal regulations.

• Instrumental in writing and producing manual to assist Research Coordinators in their responsibilities; maintain IRB form revisions; instituted monthly updated email to all Research Coordinators on offices’ new initiatives.

• Produce and assist in education segments for the department’s quarterly newsletter.

• Manage, update and maintain Office of Research Support (ORS) Team website and IRB members’ website.

• Audited and monitored IRB approved studies for Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) Compliance.

• Provide detailed guidance and assistance to new coordinator.

• Present professional and friendly presentation and collaboration with colleagues and constituents and Principal Investigator (PI).

• Review IRB submissions; study protocol applications, continuing reviews, amendments, and safety reporting.

• Attend IRB meetings; generate minutes and letters resulting from the meeting.

• Primary contact person for IRB members.

• Assist in day-to-day IRB operations since September 2011.

University of Illinois at Chicago, Chicago, IL 1998 – 2008

Project Coordinator/Clinical Research Associate, Pediatric Hematology/Oncology

• Managed clinical research trials for pediatric oncology patients.

• Coordinated and submitted studies to IRB (Institutional Review Board) in accordance to the institutional guidelines and regulations, COG (Children’s Oncology Group), and Federal Regulations.

• Assisted nurses with research protocols.

• Supported and coordinated study activities such as amendment and continuation of multiple clinical trial studies.

• Tracked and maintained records of patients participating in clinical trials.

• Maintained and upgraded studies to date.

• Performed accurate data entry into appropriate database.

TekSystems, Rolling Meadows, IL 1997-1998

Recruiter

• Qualified potential candidates based on job requirements.

• Conducted interviews for selection process in partnership with client companies.

• Advocated and assigned job placements for candidates.

• Represented the company as well as the candidates to the hiring company.

PROFESSIONAL

CERTIFICATES/TRAINING

• CCRP (Certified Clinical Research Professional), October 2011 - Present

• SOCRA member (Society of Clinical Research Associate), 2008 – Present

• ACRP member (Association of Clinical Research Professionals), 2008 – Present

• Standard Operating Procedures (SOPs) Development and Implementation workshop by SOCRA, 2011

• Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors by SOCRA (Society of Clinical Research Associates), 2010

• Clinical Research Monitoring and CCRP Certification, Preparation, and Review Course by SOCRA, 2011

• Achieved Certificate in Clinical Research Excellence by Advocate Health, 2009

• IRB 250 by PRIM&R, Public Responsibility in Medicine and Research, 2009

• Clinical Educational Conference by Northwestern University, 2009

• 2007 ASCO participant; awarded with 10.5 AMA PRA Category 1 Credits

• NIH (National Institute of Health) certified in the Human Participants Protection Education for Research Teams

• CITI (Collaborative Institutional Training Initiative) trained in the Protection of Human Research Subjects and IRB

• HIPAA Trained and compliant

• Compliance with Ethics Training

EDUCATION

Computer Systems Institute, Skokie, IL 2001

Certificate in Web Development

• 200 hour course covering Java, JavaScript, HTML, DHTML, ASP, SQL Server, Active X

Northern Illinois University, DeKalb, IL 1996

Bachelor of Science

• Public Health with emphasis on Health Administration

REFERENCE

Available Upon Request



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