Job Description

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

Responsibilities

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

Minimum Job 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

Preferred Skills and Experience:

• 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

Additional Information:

The hourly rate for this position is $40-$60. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, applicable allowances, or any additional compensation that may be associated with this role.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.