Sejal B. Shah

( ** Sayreville Blvd. S, Sayreville, NJ 08872 ( 732-***-**** (

acgbw4@r.postjobfree.com

Clinical Research Associate

Project Management Clinical Trial Planning & Oversight Cross-functional

Team Leadership

Analytical, meticulous Clinical Research Associate with exceptional success

managing multiple clinical trial studies concurrently. Regularly commended

by supervisors for exemplary troubleshooting capabilities, frequently

entrusted with studies requiring advanced skills, and consistently complete

three times the required workload by leveraging procedural efficiency

strategies. Trained in drug safety regulations, requirements, and

activities throughout the product life cycle from clinical trials,

approval, to post-marketing activities. Proficient with Microsoft Word,

Excel, PowerPoint, and SharePoint, as well as SPSS and Centerlinx Clinical

Trials Data Management System. Specific expertise includes:

( Project Management ( Team Training & Supervision ( Investigational

Product Management

( Clinical Trial Protocol & Safety ( Trial Management & Oversight (

ICH & DoH Guidelines

( Drug Safety Case Tacking ( Regulatory Requirements & SOPs ( Informed

Consent & IRB

( Individual & Aggregate Reporting ( Risk Assessment, Management, &

Mitigation ( Signal Detection & Pharmacoepidemiology

Professional Experience

Site Support Associate, LabCorp Clinical Trials, Cranford, NJ 1/2013 -

Present

. Direct operations for 30+ clinical trial studies and provide

comprehensive support to 250 investigator sites, readily managing and

resolving issues regarding samples, data, study setup, reporting, and site

compliance.

. Collaborate with specimen and data management staff to resolve arising

issues and ensure electronic data to be transmitted to customers is

accurate, free of demographics errors, and meets TAT.

. Oversee and coordinate with kits and logistics to ensure proper delivery

of supplies associated with sample receipt.

. Manage results of assigned clinical trial studies, reviewing and

distributing abnormal results, addressing queries and communicating

discrepancies, and ensuring the timely delivery of reports to

Investigators/CRAs.

. Establish and maintain accurate files on all studies as required by the

department and regulatory agencies, complete tasks in accordance with

standard operating procedures, and carry the site support "on call phone"

as needed.

Transition Unit Specialist, University of Pennsylvania Health Systems,

Philadelphia, PA 1/2011 - 6/2012

. Performed patient triage and documented results in the electronic medical

record system to support doctors and nurses.

. Discharged patients and ensured the proper management of paperwork and

organization of all relevant data.

Health Ed. & Outreach Co-op, Drexel University 11th Street Family Health

Center, Philadelphia, PA 9/2010 - 3/2011

. Educated patients on personal health and wellness maintenance by

facilitating classes on proper diet and exercise.

. Spearheaded an initiative to provide 200+ uninsured women with free

mammograms, founded the Youth Advisory Board by recruiting youth patients

and coordinating a PhotoVoice project, and led a holiday turkey and toy

drive for 200+ families.

Math & English Tutor, Score! Learning Center, East Brunswick, NJ 6/2006 -

9/2008

. Provided math and English tutoring for children ages 5 to 15,

establishing and maintaining a motivating, engaging, and empowering

learning environment.

. Collaborated and communicated with parents, discussing their child's

progress by delivering progress reports, and always demonstrated

professionalism and efficiency in a fast-paced environment.

Community Leadership

Volunteer, St. Peter's Hospital, New Brunswick, NJ 2/2005 - 8/2012

. Completed over 300 hours working side-by-side with physicians and helping

to transport patients, provide support in the ER, greet families, assist

patients with requests, provide personal patient care, and help them feel

comfortable in the hospital.

Lindy Advisor, Phillip B. Lindy Scholars, Philadelphia, PA 9/2009 -

6/2012

. Taught math and literacy to inner-city middle school youth in

Philadelphia, developing and delivering the instructional curriculum, and

mentoring children by counseling them on everyday life problems.

Education & Credentials

Bachelor of Science in Health Sciences, Minor: Health Service

Administration, Drexel University, Philadelphia, PA 2012

Clinical Research Associate Training ~ Drug Safety Training, The Veritas

Healthcare Solutions LLC

Sejal Shah ( 732-***-**** ( acgbw4@r.postjobfree.com

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