Clinical Trial Associate (CTA)

A prestigious pharmaceutical company in the Boston area is currently seeking an entry-level Clinical Trial Associate (CTA), aka Drug Safety Associate. As the CTA you will be responsible for assembling information, dating stamp, imaging source documents, and creating paper and/or electronic folders. This is an excellent opportunity to jump-start your career with a well-respected organization!

Pharmaceutical Company

As the CTA, you will:

• Assemble information, date stamp, image source documents, create paper and/or electronic folders, associate electronic/paper information to electronic/paper folder as appropriate
• Verify the presence of all information required to be a case (product, reporter, event, and patient), and request critical missing information for non-cases by expeditiously contacting the reporter
• Identify duplicates and non-cases, as well as incorporate physician input, append case files and perform in-process quality review for case receipt
• Submit/provide MedWatch/CIOMS I/E2b reports as applicable
• Generate and work with other team members to send a follow-up letter/queries to the appropriate reporter using the most expedient mechanism, forwarding to clinical sites where appropriate
• Identify database cases eligible for archiving
• Perform reconciliation with licensing partners and CROs to ensure compliance and accurate receipt of all adverse event information

• B.S. / B.A. in Life Sciences
• Some industry/clinical experience working with medical/hospital/scientific records, preferably in Clinical Research, Drug Safety, or Clinical Data Management
• Experience with medical/hospital/scientific records
• Familiarity with medical terminology and experience with data entry processes
• Proficiency in recent versions of MS Word, Excel and Access
• Excellent communication skills
• Competence in handling numerical data or organizing information in tabular displays

$

• New graduate/entry-level R.N., B.S.N., PhD with 1+ years clinical experience