Campus Pride Jobs

Overview
The Clinical Trial Associate (CTA), Clinical Operations will support the clinical project team in the operational execution of clinical trials.
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 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 and 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 & Experience
Strong written and verbal communication skills
Strong computer skills including proficiency in use of Microsoft Word and Excel
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, NJ

Essential Physical Requirements
Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Ability to view video display terminal images
Ability to operate a computer keyboard and telephone.
Ability to sit for extended periods of time - up to four (4) hours at a time.
Ability to lift, tug, pull up to fifteen (15) pounds.

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. DISCLAIMER The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.
EEO
Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, 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 in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.


Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity