Project Management

MONALI. B. PATEL

Address: *** ****** ******, *** *, Jersey City, NJ, 07307

E- Mail: *************@*****.***

Contact No: 201-***-****

EXPERIENCE SUMMARY

> Extensive knowledge of phase II, III clinical trials

> Extensive monitoring and site management experience including, pre-

study, initiation, routine, and close-out visits at investigator sites

for GCP and protocol compliance according to client SOPs/guidelines

> In-depth understanding of drug development process, GCP/ICH regulation

> Skilled in training the site personnel on protocol related procedures,

safety reporting, regulatory requirements,

> Work with cross functional study team to ensure timely and quality

data collection

> Sound understanding of the medical terminology, comfortable working

with MDs and RNs

> Excellent organizational and problem-solving skills

> Proven ability to work independently

PROFESSIONAL EXPERIENCE

Technical Resources International, Bethesda, Maryland

June 2013-Present

In-House CRA

> Review essential documents for accuracy and completeness as required

by FDA regulations, ICH GCP, Sponsor's requirement and SOPs

> Essential regulatory document collection, tracking and transmittal

> Review and process documents for site activation, interim and close

out

> Maintain Trial Master File and track the process in clinical trial

management system

> Troubleshoot ERD issues

> Serve as a liaison between the sponsor and the sites

> Assist with the maintenance and QC of the Trial Master File

> Track study progress and maintain study status update

> Resolve any outstanding issues with sites

Beardsworth CRO, Flemington, NJ

Sept 2010 - Apr 2013

Clinical Research Associate

> Monitored Oncology phase II, III trials

> Served as a liaison between the sponsor and the sites

> Performed site feasibility/evaluation visit ensuring that site has

the ability to conduct according to ICH GCP guidelines and protocol

requirements

> Performed site initiation, routine monitoring and close-out visits

according to applicable sponsor SOPs and regulatory guidelines

> Ensured that all site personnel involved in the study are adequately

trained and has sound understanding of the protocol requirements,

performed source data verification, reviewed protocol compliance and

adverse/serious adverse events reporting, performed drug

accountability

> Maintained regular and effective verbal and written communication

with clinical project management team members

> Developed a comprehensive knowledge of the clinical study protocol

and other relevant documentation

> Obtained key GCP documents prior to site initiation for appropriate

filing and distribution. Maintain updated clinical study site and in-

house files for the duration of the clinical study.

> Maintained regular contact with the investigator and site staff by

means of letters, emails and weekly telephone calls. Provide site

with necessary study updates and documents. Monitor site adherence

to the protocol and regulatory procedures, and provide ongoing site

support and training for study procedures.

> Developed and maintained a working knowledge of current SOPs and ICH-

GCP & FDA requirements. Attend training courses and seminars as

designated by senior clinical management.

Exodon, Mt. Arlington, NJ

May 2009 - Aug 2010

Clinical Research Associate

> Monitored (pre-study, initiation, routine, and close-out visits) at

investigator sites for GCP compliance according to SOPs and/or client

guidelines

> Generated study specific documentation including monitoring trip

reports, telephone contact reports, site correspondence, and expense

reports.

> Recruited investigators for participation in clinical trials

> Conducted project feasibility assessments

> Obtained, review for appropriateness, and process regulatory and

administrative documents from investigator sites, performed drug

accountability

> Reviewed draft protocols for completeness and feasibility

> Developed Case Report Forms for clinical trials

> Presented (e.g. study specific guidelines and procedures, case report

forms, and monitoring conventions) at Investigators' Meetings

> Prepared and process Serious Adverse Event (SAE) reports, according to

plan

> Prepared project management reports for clients

> Resolved queries of CRF data with study site personnel

Eli Lilly and Company, Ahmadabad, India

Dec 2005 - Jan 2008

Clinical Research Associate

> Assisted in the development of clinical trial protocols (Oncology),

summaries and clinical documents

> Prepared and implemented project training materials for internal and

external staff

> Reviewed clinical templates and documents for accuracy like Informed

Consent, Source documents, TMF's (trial master files).

> Coordinated with multidisciplinary project teams in providing clinical

research expertise to support other departments and line functions

> Maintained study related regulatory documents at the site

> Performed routine monitoring of clinical sites doing SDV (source

document verification)

Assist with entering patient data into EDC database, answer queries and

work with other monitors to resolve issues.

EDUCATION

Masters of Science in Medical Microbiology

Long Island University, New York

GPA: 3.6

Medical Laboratory Technology

Gujarat University, India

US equivalent GPA: 4.0

Bachelor of Science in Biology

Gujarat University, India US

equivalent GPA: 3.2

REFERENCE: Available Upon Request

Contact this candidate