RAJNEESH REGHUNATHAN

Porter Ranch, CA

909-***-****

ac505f@r.postjobfree.com

WORK EXPERIENCE

Regulatory Affairs Project Manager

UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA 07/2017-Current Manage study start-up activities for phase I-III clinical trials from initial sponsor contact, through protocol inception to trial activation. Responsibilities include, but not limited to the following:

• Create regulatory documentation/submissions required for the opening of new studies to local IRB

• Organize, prepare and maintain all essential regulatory documentation required by sponsor or CRO (1572s, Financial Disclosure Forms, Training and Delegation Logs, CVs and Medical Licenses and laboratory certifications)

• Build clinical trial budgets and negotiate them

• Work with legal team to facilitate preparation of clinical trial agreements

• Disseminates information to medical and nursing staff related to ongoing and upcoming clinical trials

Highlight: Over 93% success rate in opening industry sponsored studies. Clinical Research Coordinator & Site Development Associate Care Access Research, Los Angeles, CA 04/2016-05/2017 Primary study coordinator for phase III/IV, industry-sponsored, clinical research trials in the area of cognitive Impairment and Alzheimers disease, responsibilities include, but not limited to the following:

Clinical Research Coordinator:

• Chart review and screening

• Consenting research participants

• Lab and specimen processing and shipment

• Data management

• Investigational product accountability

• Quality assurance

• Support the team and investigators in overall conduct of the trials Site development:

• Conducted pre-study site selection visits and assessments

• Ensured site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct 1 /2

Highlight: Assisted in site development strategies for two private practices in Southern California with successful procurement of industry sponsored studies that met enrollment quotas.

Clinical Research Coordinator

VA Loma Linda Healthcare Center, Loma Linda, CA 09/2014- 5/2016

• Reviewed new patient records and screens patients for eligibility for participating in research protocol

• Consented patients, and interviews patients to collect data on health history and lifestyle practices

• Maintained paper and electronic source document and case report e.g. progress notes, medical history and laboratory results

• Ensured that non-serious and serious adverse events were properly identified, documented and reported per all applicable protocol requirements

• Safeguarded the proper collection, processing and shipment of bio-specimens Clinic Office Manager

Your Personal Healthcare, INC., Chino Hills, CA 11/2015-05/2016 Dr. Tahseen Shareef INC., Loma Linda, CA 07/2014-05/2016

• Managed clinical, administrative, and clerical staff of two Primary Care Practices

• Made practice more efficient through workflow improvements, detail-oriented process changes, and increased focus on customer satisfaction

• Trained and hired personnel and maintained employee files

• Assisted in reviewing vendors contracts and invoices

• Managed and maintained office supplies and equipment inventory Medical Assistant

Dr. Tahseen Shareef, Loma Linda, CA 07/2013-06/2014 Physician

University Hospital, Malaysia 04/2012-09/2012

EDUCATION

• MD, Kursk State Medical University, Russia 06/2011

• Business Analysis, UCLA Extension Expected Fall 2018 CERTIFICATIONS

• Certified Phlebotomy Technician, National Healthcare Association, 02/2017

• Certified on the following cognitive scales: MMSE, ADAS-cog, RBANS, Qol-AD, AD8, NPI, EQ-5D, Rud-Lite, Bracket, 2016

• Good Clinical Practice, Citi Training, 2016

• IATA, VA Loma Linda Healthcare Center, 2015

• Educational Commission for Foreign Medical Graduates (ECFMG) Certified, 09/2012 2 /2

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