Temp-Clinical Outcomes Assessment Specialist

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Clinical Outcome Assessment (COA) Specialist is responsible for working directly with COA Manager to provide technical and general administrative support for assigned eCOA studies including but not limited to; managing and overseeing COA license agreement, supporting with managing COA translations, compliance monitoring, User Acceptance Testing (UAT) execution, documentation management (IRB/EC & TMF) and study decommissioning.  Possessing strong attention to detail, effective communication skills and robust organizational abilities, the COA Specialist will work collaboratively with other business units (e.g. Clinical Trial Management, Procurement, Legal, Finance), external eCOA vendors and Clinical Research Organizations (CROs) to ensure timely completion of all study related activities.

JOB DUTIES:  

• Provides general day-to-day eCOA support working with vendors and internal cross functional teams

• Ensure smooth study operation with strong communication skills escalating COA project operational risks to their manager

• Reviews and monitors eCOA Compliance for one or more assigned studies, and advances issues related to compliance to the COA manager, contributes to compliance action plan development and implementation

• Supports UAT strategy and execution by reviewing test plan, test scripts and conducting UAT.

• Supports the coordination, management, and reconciliation of study related eCOA documentation in Trial Master File

• Supports the COA Manager, with COA research to determine appropriate copyright holder and establish licensing requirements

• Secure necessary clinical outcomes assessments permissions and license agreements (including Master Service agreements, where appropriate) to ensure alignment with new and/or updated license agreements through collaboration with the following internal functions: Legal, Procurement, Health Economics & Outcomes Research, Finance

• Track and communicate licensing agreement status and serve as central point of contact for internal and external stakeholders for licensing agreements in clinical trials

• Review licensing invoices for pass through costs in coordination with Clinical Study Lead and COA manager; and ensure payment of appropriate license fees is completed

• Receive and catalog source documents (English and translations) as received from the license holders and translation vendors

• Track and maintain database of license holders, ensuring compliance with terms and conditions of relevant contracts

• Provide support for problem resolution between licensing holder and Regeneron study team

• Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives

• Proactively recommends process improvement initiatives for the department

• May require up to 25% travel

JOB REQUIREMENTS:

• General knowledge and awareness of systems development processes

• Ability to acquire working knowledge of copyright law and licensing/permission requirements for COAs

• Effective verbal and written communication skills

• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

• Ability to proactively recognize project challenges, implement action plans, and escalate risks in a timely manner

• Strong organizational and attention to detail

• Ability to support and build collaborative relationships both internally and externally

• Basic familiarity of clinical drug development preferred

• Bachelor’s degree and minimum of 3 years relevant industry experience. 

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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