Research Assistant 226622

We are looking for a Research Assistant to join our growing team- this is a full time onsite position. We offer a competitive salary, bonus potential and have a great benefits package.

If you are looking to join a site that is part of a national organization with lots of room to grow, this is the role for you.

Position Summary

The research assistant is primarily responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and / or manual of procedures.

Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.

Education :

• High School diploma or the equivalent, with significant relevant experience
• College degree preferred

Experience / Knowledge / Skills :

• Effective oral and written communication
• Delivers safe and appropriate care to patients in addition to the requirements outlined by
• study protocols

Duties

• Assist Coordinator in CTMS management
• Review and resolve data management queries as needed
• Inform subjects and obtain written consent in regard to ICF’s (on selected studies)
• Observe and assist scribe in ocular exams for doctors and confirm appropriate treatment per protocol
• Submit images to CRCs as needed
• Assist and perform unmasked duties for ISTs and Phase 1 studies, including maintaining IP and shipping logs
• Perform Serious Adverse Event reporting, initial & follow up reporting, including the prompt request of all necessary medical records, review of medical records and updated reporting
• Train and understand all aspects of regulatory compliance
• Assist Coordinator in regulatory management, including training and monitoring visits
• Transcribe and perform query resolution regarding subject study information from source documents to the Electronic Case Report Forms
• Coordinate and schedule subject visits within study / subject specific windows per protocol guidelines.
• Prepare visit-specific documentation and charts for Clinical Research Coordinator
• Observe Coordinator in patient care and management
• Assist Coordinator in monitoring subject flow and assist in subject care and management
• Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.

study visits (Phase 2 & 3; NO Gene Therapy)

• Transcribe subject study information from source documents to the Electronic Case Report Forms
• Administer all mandatory questionnaires to study subjects
• Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol
12 days ago