George Tabulov, BSc, CCRP

** ****** *****, *****, *******, L6A 4N7, Canada

Tel: 416-***-****

adc6t5@r.postjobfree.com

Certifications & Qualifications:

ICH GCP Training by CITI including Division 5 (2019);

Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors - SoCRA (2017);

CRA Professional Development Program (ICH GCP) - SoCRA (2018);

SoCRA member since 2006;

Therapeutic Areas:

Cardiology – 7 years;

Endocrinology (Diabetes Type II) – 5.5 years;

Oncology – 7 years;

Dermatology – 7.5 years;

Hematology – 3.5 years;

Medical Devices – 4.5 years;

Ophthalmology – 2.5 years

Allergies – 1.5 years;

Schizophrenia – 1.2 years (Inpatient);

Bipolar – 1.5 years;

Pain studies (Narcotics) – 2 years.

Professional Experience:

Senior Clinical Research Associate

Independent Contractor, 2019 (February) – 2020 (April) – Synergy (CRO)

Senior Clinical Research Associate/Lead Clinical Research Associate

Independent Contractor, 2014 (October) – 2019 (January) – ICON Plc (CRO)

Senior Clinical Research Associate,

Independent Contractor, 2010 (March) – 2014 (September) – INC Research (CRO);

Senior Clinical Research Associate/Lead CRA

Independent Contractor, 2012 (September) – 2013 (October) – Stellargenes France (Sponsor);

Senior Clinical Research Associate,

Independent Contractor, 2008 (April) – 2010(March) - Quintiles Canada (CRO);

Senior Clinical Research Associate,

Independent Consultant 2006(May)-2008 (April) - The Canadian Heart Research Center (CRO);

Clinical Research Associate,

Full Time, 2003(October) - 2006(October) - Endpoint Research (CRO).

Professional Skills:

Extensive ICH GCP training and in-depth knowledge of ICH GCP guidelines;

Experienced in pre-trial assessments, site initiation, routine monitoring and close-out;

Conducted remote monitoring visits per monitoring plan;

Profound knowledge of risk-based monitoring;

Experience with preparation of sites for regulatory and sponsor audits and inspections;

Experienced with monitoring AEs, SAEs, Pregnancies according to ICH-GCP and Division 5.

Ensured Query Resolution process to prepare sites for database locks;

Verified subject safety and site adherence to FDA Regulations, ICH/GCP Guidelines and Protocol;

Assist in the preparation of protocols for scientific and ethical review;

Managed site regulatory binder’s contents and work with sites to ensure communication requirements between site and IRB;

Ensured complete and thorough study drug accountability, reconciliation and collection;

Completed Confirmation Letters, Visit Reports, and Follow-Up letters in a timely manner;

Verified accurate source documentation, validate CRF entries and assist with query resolution (Conducted source data verification);

Profound experience with IVRS/IWRS, EDC (Inform, Medidata)

Management Experience:

Site Allocation for CRAs

Interviewing new CRAs

Manage workload for CRAs

Conducting performance meetings/appraisal meetings

Review of monitoring reports (QPPVs, SIVs, IMVs, COVs)

Personal Skills:

Outstanding organizational and communication skills

Strong oral, written and presentation skills

Capable of prioritizing multiple tasks under the pressure of deadlines

Self motivated eager learner

Able to work without supervision and take responsible decisions

Education:

B.Sc. Honors Biotechnology, York University, 1999-2003

SoCRA certificate - 2006

Computer Skills:

Microsoft Office: Outlook, Excel, Word, Access, Power Point;

OS: Windows 2000, 2003, XP, Vista.

CTMS, eTMF, IMPACT

EDC: Medidata – 8 years, In Form – 8 years, Oracle – 6 years

References:

References and certifications are available upon request.

Contact this candidate