Contract - Clinical Trial Associate, Clinical Operations

Shionogi Inc.•Florham Park, NJ

5d•$40 - $60•Onsite

About The Position

The Contract Clinical Trial Associate (CTA), Clinical Operations will support the clinical project team in the operational execution of clinical trials.

Requirements

BS/BA in Life Sciences preferred or demonstratable equivalent work experience
Minimum 1-year pharmaceutical industry experience in clinical development involved with Clinical Trials
Must possess basic knowledge of applicable clinical research regulatory requirements including, Good Clinical Practices (GCP)
Must have basic knowledge of applicable protocol requirements
Experience with invoice review and processing

Nice To Haves

Strong written and verbal communication skills
Strong Computer skills including proficiency in use of Microsoft Word, Excel and
Effective time management and organizational skills
Self-starter, problem solver, self-motivated, actively seeks to increase responsibility
Background should include experience with calendar management; invoice review, budget management; meeting planning
Attention to detail and accuracy in work
Strong customer service
Must live a commutable distance to our US Corporate Headquarters in Florham Park, New Jersey

Responsibilities

Update and maintain clinical systems within project timelines and review files for accuracy and completeness
Support the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the Clinical Trial Manager (CTM)
Support inspection readiness
Prepare, handle and distribute of Clinical Trial materials and maintenance of tracking information
Act as a central contact for the clinical team for designated project communications
Schedule Project related meetings, attend operational team meetings, write and/or review meeting minutes, distribute minutes and follow-up actions
Assist with preparation of meeting materials, presentations,
Prepare, handle, distribute, file and archive clinical documentation and reports according to standard operating procedures. Assist with identification of potential clinical sites; maintain investigator lists
Support organization of investigator meetings/advisory boards
Review of study files periodically for accuracy and completeness
Track and manage Case Report Forms (CRFs), queries and clinical data flow
Utilize JDE system to monitor funds on existing purchase
Manage tracking of all Clinical operations contracts generated (i.e. coding, approvals, filing, etc.) and associated invoices
Other duties as assigned