Clinical Trial Assistant

4678BR
Clinical Operations
Woodcliff Lake, NJ
May 7, 2019
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Description

Supports all phases of clinical study activities (feasibility, start-up, maintenance, and close-out).
• Responsible for TMF review – inspector ready.
• Assist with filing and archiving project documentation in the eTMF within 20 day timeframe.
• Assist with creating, updating and maintaining project trackers in EPIC.
• Assist with creating, updating and maintaining timelines in EMMI.
• Assist with monitoring visit report review in order to maintain oversight of clinical monitoring quality and adherence to protocol, and established processes and plans.
• Provides support for document preparation (e.g, Informed Consent Form, TMF Filing Plan, Co-Monitoring Plan).
• Attend internal study team meetings, and prepare and distribute study team agendas and minutes.
• Attend CRO teleconferences/meetings when applicable.
• Track clinical trial site agreements and upload to EPIC project space.
• Prepare requests for clinical trial insurance.
• Review regulatory packet for initial investigational product release.
• Assist with investigator meeting planning meetings, including entering clinical meetings into the HEAT system and EMMI.
• Attend investigator meeting when applicable.
• Track and manage all study vendor invoices.
• Act as a central point-of-contact for the clinical team for designated project communications, correspondence and associated documentation.
• Completes work within set time frames.
• Other duties as assigned.

Qualifications

– Education: Bachelor’s degree in the life sciences or related field required.
– Responsible for TMF Review – inspector-ready.
– 1-3 Years relevant work experience; Clinical Operations experience preferred.
– 1 or more years electronic Trial Master File experience.
– Ability to work semi-autonomously with strong organizational, prioritization and analytical skills.
– Good written and oral communications skills.
– Ability to liaise with other functional areas on study or non-study related matters.
– Effectively manages time to meet task/project deliverables and deadlines in a manner that minimizes rework.
– Strong ability to multi-task in a fast paced environment.
– Takes appropriate care to ensure quality of data and work outputs.
– Keeps team and supervisor informed and up-to-date on information directly related to own position in the clinical operations study team.
– Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.