System One CTA in Florham Park, New Jersey
Position Title: Clinical Trial Associate, Clinical Operations
Department: Clinical Development
Scope of Assignment:
The Clinical Trial Associate (CTA), Clinical Operations will support the clinical project team in the operational execution of clinical trials.
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, etc.
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 orders.
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 demonstrable 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 PowerPoint.
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 orientation.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.