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Clinical research associate

Edison, New Jersey, 08817, United States
October 19, 2016

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C: 732-***-****


Seeking a Clinical Research Associate position where I can apply my skills and experience in a professionaland challenging position thereby, contributing towards the organization's vision and objectives.


Excellent knowledge of Clinical Trial Management System (CTMS), Clinical Data Management (CDM) /Oracle clinical (OC), Clinical Project Management.Working knowledge of Clinical Data Management Tools : Oracle Clinical and SAS.Proficient with regulated clinical trial environment and knowledge of the drug development process.Extensive knowledge of Clinical Practices, Clinical trial methodologies, Design Controls, ICH-GCPGuidelines, FDA guidelines.Knowledge of HIPAA and 21 CFR Part 11.Procedural knowledge of FDA audit.Ability to maintain excellent working relationships with a broad range of trial staff.Excellent ability to handle multiple tasks and many administrative details in a fast-paced and constantlychanging environment by efficiently organizing and prioritizing work .Self-starter with excellent interpersonal, verbal, and written communication skills with the ability tosucceed in both independent and team environments by demonstrating attention to details.Strong critical thinking, problem solving and analytical skill sets with computer proficiency in MS Office.


Cardiovascular - Phase III

Endocrinology - Phase II


Clinical Research Associate Intern, 03/2016 to 06/2016

Sollers – Edison, NJ

Supervised assigned sites to ensure quality and integrity of data by complete source data verification.Monitored the trial at site following the SOP with adherence to the ICH-GCP and applicable regulatoryrequirements.Developed and maintained collaborative working relationships with clinical investigative sites.Accountable for patient safety and regulatory compliance for all assigned sites.Reviewed study case report forms (CRFs) completed by the investigative sites, and verified entries byvalidating accurate source documentation to support CRF entries.Conducted in-house monitoring and generated timely and accurate monitoring reports, confirmationletters and follow-up letters for all site visits.Reviewed all SAEs, ensured Medical Director sign-off, checked that sites are notified and that all companyprocedures are complied with.

Verified the receipt, handling, accounting, storage conditions, and availability of investigational productsat the site. Reviewed and reconciled all essential documents of the Trial Master File (TMF) in accordance with SOPs.

Performed ongoing reviews of TMF with SMF to assure quality of the documentation files and compliancewith SOPs, GCP and ICH Guidelines.Liaised with Business Management to secure confidentiality agreements, master service agreements,clinical trial agreements as appropriate. Used this information to prioritize sites for approval.

Assisted the project team in preparation for audits/inspections and was responsible for the quality andcompleteness of clinical trial documentation.Helped the site staff by training and retraining them on protocol requirements.

System Administrator, 06/2008 to 12/2008

Blue Bharath Pvt Ltd – Chennai, India

Job responsibilities included maintenance of computer systems including hardware and software supportand reconciling company data.Software support included formatting systems, loading operating systems, configuring the system andinstalling programs including Microsoft Office suite.Helped resolve virus outbreak as member of a team that quickly isolated and removed virus from thesystems.Commended for technical, analytical and problem-solving skills; effective task prioritization; andcustomer service orientation.

Project Trainee, 12/2007 to 03/2008

Anna University, National College of Engineering – Tirunelveli, India

Worked as a project trainee in the Research and Development Department.Providing technical support and aiding the developmental research projects, which Includes testing ofthehardware / software manufactured for a wide variety of applications.


Bachelor of Technology: Information Technology, May 2008

Anna University, National College of Engineering - Tirunelveli, INDIA


Clinical Trial Management (CTM) Certification at SOLLERS


Clinical Trial Management System (CTMS) Operating systems : WINDOWS XP/2003, Solaris 8Regulatory Medical Writing Programming: C, C++, Java, .NET, SAS

Clinical Data Management (CDM) / Oracle Database : Oracle Clinical, Oracle 6, SQL Server

Clinical (OC) Packages: MS Office Suite (Word, Excel, Power Point),Clinical Project Management (CPM) Adobe Photoshop, Flash, Anti-virus.Statistical Analysis Software (SAS)

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