Clinical Research Associate

Gerald Chu Meh

*** * **** ****** # *** Hoffman Estates, Illinois, 60169

Cell: 773-***-****,**********@*****.**

Professional Summary

A professional Clinical Research Associate with extensive track records on several large multi-center, randomize,

double-blind, placebo-controlled clinical trails

Skill Highlights

Detail Oriented Multi-tasking

Strong organizational skills Fast learner

Team Player Great leadership skills

Great Interpersonal skills

Work Experience

Regional Clinical Research Associate

April 2011 to Current

Vertex – Coralville, Iowa

• Complete Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs and

complete reports to quality standards within company specified timelines.

• Responsible for all tasks related to the monitoring and management of clinical trials for assigned sites.

• Monitor Phase I-IV clinical trials, assuring adherence to Good Clinical Practice

• Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites.

• Attains thorough understanding of study management tasks and responsibilities necessary to implement

compliance with protocol/regulatory requirements and Vertex SOPs.

• Attends Investigator Meetings and study-specific training for assigned trials.

• Collaborates with the Lead CRA(s) to obtain/share trial specific issues across all study sites concentrating on

areas related to quality, site performance and metrics.

• Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and

CRAs as appropriate.

• Complete follow up letters for all visit types according to SOPs and complete reports to quality standards within

company specified timelines.

• Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data

integrity, patient safety and regulatory compliance for all assigned sites.

• Monitors recruitment and data quality while on site and remotely through EDC systems/communication with

sites.

• Performs on-site drug accountability and reconciliation.

• Verify drug storage and ensure that drug handling meets protocol and SOP requirements.

• Responsible for maintaining current Investigator Site File (ISF) in accordance with Vertex SOPs. Performs

ongoing reviews of ISF to assure quality of the documentation files and compliance with Vertex SOPs, GCP and

ICH Guidelines while on site.

• Responsible for assuring adequate and appropriate dissemination of information according to the study specific

communication plan between project team members to ensure project success in accordance with the CTM

Communication Pathway or Project Specific Communication Plan.

• Understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are

met across assigned sites

• Assists the project team in preparation for audits/inspections and is responsible for the quality and

completeness of site related performance and documentation.

Home-Based Clinical Research Associate

May 2010 to April 2011

KemPharm – North Liberty, Iowa

• Perform all types of site visits including: site qualification visits, site initiation visits, interim monitoring visits, and

close out visits to ensure that study is conducted according to the protocol, ICH GCPs and all applicable

regulations.

• Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and

case report form completion.

• Ensure that the rights, well-being and safety of human subjects are protected.

• Manage, prepare, send, track, and return investigational supplies at individual sites.

• Monitor and document investigational product dispensing, inventory, and reconciliation.

• Monitor and document laboratory sample storage and shipment.

• Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring

visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities.

• Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify

and resolve ongoing data issues.

• Review data queries and listings, and working with the study centers to resolve data discrepancies.

• Review regulatory documentation for accuracy and completeness, and support study centers with regulatory

issues.

• Maintain complete and accurate study files, and review files to ensure all appropriate documentation is present.

• Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and

other individuals involved in clinical trials.

• Perform other tasks or responsibilities as assigned.

• Mentor junior level CRAs and serve as a resource for newly hired CRAs

• Act as primary liaison for assigned study sites and convey appropriate project information, answer questions

and escalate issues as necessary to the Lead CRA or project management.

Clinical Research Associate

November 2008 to May 2010

Penwest Pharmaceuticals Co. – Patterson, NY

• Perform and coordinate all aspects of the clinical monitoring process in compliance with ICH/GCP guidelines

and other regulatory agency guidelines.

• Conduct site visits to determine protocol and regulatory compliance and prepare required documentation.

Ensure that the data reported in site source documents is accurate, complete and verifiable.

• Perform drug accountability at site visits to ensure proper preparation, handling, dosing and storage of drugs.

• Review investigational trial files to ensure completeness and retrieve documents as appropriate for the

sponsor’s trial master file.

• Maintain ongoing and continuous professional communication with the clinical site and the study team

throughout the duration of the study.

• Assist with site selection as directed by team members.

Clinical Research Assistant

August 2007 to November 2008

Penwest Pharmaceuticals Co., Patterson, NY

• Provide logistical support for conduct of clinical studies by communicating with CROs

• Maintain, update and establish various databases for study tracking

• Assist with archiving of study materials

• Review documentation and maintain records of study conduct and data

• Take accountability for planning, organizing and overseeing the shipment of study supplies to the investigational

sites

• Work closely with clinical operations group and assist with clinical pharmacology sample tracking, shipments,

data processing and reconciliation

• Provide support to the field based team and assist with setting up, monitoring, execution and maintenance of

clinical studies.

• Work closely with the clinical operations personnel, plan and coordinate all operational activities required for the

conduct of clinical studies

• Act as first point of contact for monitors/CRO partners regarding all aspects of the clinical study

Project Coordinator

February 2006 to August 2007

Andy Frain Service, Waukegan IL, 60085

• Attend client meetings and assist with determination of project requirements

• Assist the PM in the drafting and issuance of project proposals

• Assist in the design and implementation of projects

Education and Training

BSc in Political Science and Public Administration

University of Buea – Buea, Cameroon

Master in Public Policy

University of Northern Iowa- Cedar Falls, Iowa.

Clinical Research Orientation Training - Penwest Pharmaceuticals

ICH GCP Training – Penwest Pharmaceuticals

Contact this candidate