DHARABEN PATEL

Email: k1y9b1@r.postjobfree.com

Mobile- 772-***-****

OBJECTIVE:

To become a value based accomplished scientist in the field of clinical research with personal and professional goals wherein my prior experience of safety reporting, monitoring, reviewing of research data, clinical study report making, training, management skills and education would be utilized to adopt different methodology to improve the quality of delivering and to become part of a committed research team in order to bring benefits scientific knowledge for suffering population.

QUALIFICATION SUMMARY:

• Dedicated and focused Clinical Research professional that provides support, coordination and leadership for drug studies that may involve industry sponsored Phase-I, II and III clinical trials

• Detailed knowledge of ICH-GCP guidelines.

• Familiar with CFR components and regulatory requirements.

• Pharmacovigilance

• Extraordinary ability to problem solving and presentation skills

• Ability to recognize and appreciate with cultural differences

• Good communication, documentation and conflict management skills

• Good team player, Flexibility and adaptability concepts

EDUCATION:

M.Sc. in Clinical Research 2009

Institute of Clinical Research India

(Cranfield University, UK), Ahmedabad,India

Post Graduate Diploma in Clinical Research Management 2008

Institute of Clinical Research India

(Cranfield University, UK), Ahmedabad,India

Medical Laboratory Technician 2007

V.S.Hospital, Ahmedabad, India

Bachelor of Science- Microbiology. 2006

Gujarat University Collage, India

CERTIFICATION:

Certified Clinical Research professional (CCRP) Jun-2012

(Through SoCRA (Society of Clinical Research Associate)

PROFESSIONAL EXPERIENCE:

Sr. IRA (International Regulatory Affairs) Officer- Claris Life Sciences Ltd.

(Sep 2010 to Dec 2011)( Pharmacovigilance Department)

Responsible for:-

• Scheduling, preparation, quality review and reporting of PADERs and PSURs to the various Regulatory Authorities in European and non-European territory.

• Preparation of Reporting plan for ADRs for different countries

• Coordinate between QP-PV, QA, regulatory and business partners on ADE information.

• Maintain the SoP up to date and ensure these are being followed in totality.

• Response to the Regulatory PV Queries

• Archive and preserve the safety documents electronically and physically.

• Keep updated on the recent changes in the safety regulations and ensure these are compiled through SoP and contract/agreements.

• Daily coordination with Qualified Person for Pharmacovigilance

• Coordination with the different EU and Non-EU partners for Pharmacovigilance issues

• Monthly Review Presentation for the Pharmacovigilance

Clinical Research Coordinator – Bankers Heart Institute, India

(Aug 2009 to Jul 2010)

Responsible for:

• Conduct of clinical trials in compliance with the protocol, hospital SOPs, GCP and applicable regulatory guidelines

• ICF presentation and ensure that ICF is done before screening and participation of subjects in clinical trial

• Notification of safety reports to Ethics committee

• Documentation in e-CRF and paper CRF from source documents

• Monitoring and reporting of trial related activities to Sponsor, Clinical Research Associate, IEC, Principle investigator, co-investigator, sub-investigator and internal department

• Handling external audits from sponsor and regulatory departments

• Checking shipments and storage of investigational products

• Maintenance of study files and source documents

• Notification of safety reports to Ethics committee

• Maintaining investigators site file

Jr. Laboratory Technologist-Rajguru Pathology Laboratory, India.

(Sep 07 to Jan 2009)

Worked in different type of departments as follow:

Clinical Biochemistry, Hematology, Coagulation and serology, Urinalysis, Immunology, Blood Bank, Microbiology.

COMPUTER SKILLS:

• Excellent command over Microsoft Word, Excel & power point

• Good working knowledge of Microsoft project plan for preparation & tracking of timelines

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