Clinical Trial Assistant / Coordinator
The Clinical Trial Assistant/Clinical Trial Coordinator will be responsible for coordinating patient study visits and procedures, while working with an investigator in the scheduling, preparation and provision of education and information regarding clinical protocol(s) to associated health care personnel and study subjects. This individual will collect and maintain a file of regulatory documents, study documentation and communication for each study, obtain informed consent from potential study candidates, and consistently track and update subject participation in database. Overall, the CTA will provide a range of project and operational support to multiple cross-functional Study Teams through all phases and stages (start-up, conduct and close-down).
- Scheduling meetings, preparing meeting agendas and minutes, and archiving agendas and minutes in the clinical trial master file (TMF).
- With supervision, assembling startup document packets, site reference binders, study worksheets, newsletters, and similar materials.
- Distributing study supplies and other materials to clinical sites.
- Circulating training materials and maintaining training records.
- With supervision, entering investigator, investigative site, and vendor information into the Clinical Trial Management System (CTMS).
- Distributing and tracking safety mailings (including IND safety report notifications).
- With supervision, printing and distributing clinical data for review and reconciliation by study team members.
- Maintaining Clinical Operations and study team calendars.
- Tracking study documents and significant communications for assigned study(ies).
- With supervision, receiving, categorizing, and filing essential documents into the TMF.
- Performing other activities as assigned
- Bachelor’s degree (or equivalent experience) with experience in a clinical research or healthcare related industry
- 2-4 yrs. of clinical research coordinating experience.
- Familiarity/Experience with Clinical Trials and the Pharmaceutical Industry preferred.
- Experience working as part of a large, fast-paced team within the biotech/pharmaceutical industry,
- Good written and verbal communication skills.
- Proficient computer skills across multiple applications.
- Strong organizational skills and attention to detail.
- Highly proficient in Microsoft Office Suite (including MS Word, Excel, PowerPoint and SharePoint),