Clinical Outcomes Assessment Specialist - Temp

Location
Tarrytown, NY, United States
Posted
Jun 13, 2021
Ref
24410BR
Required Education
Bachelors Degree
Position Type
Contract
The Clinical Outcome Assessment (COA) Specialist is responsible for working directly with COA Manager to provide technical and general administrative support for assigned eCOA studie. This includes leading and overseeing COA license agreement, supporting COA translations, compliance monitoring, User Acceptance Testing (UAT) execution, documentation management (IRB/EC & TMF) and study decommissioning. In this role, you 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.

In this role, a typical day might include:
  • Providing general day-to-day eCOA support working with vendors and internal cross functional teams
  • Ensuring smooth study operation and raising COA project operational risks to their manager
  • Reviewing and monitoring eCOA Compliance for one or more assigned studies
  • Raising issues related to compliance to the COA manager and contributing to compliance action plan development and implementation
  • Supporting UAT strategy and execution by reviewing test plan, test scripts and conducting UAT.
  • Support the coordination, management, and reconciliation of study related documentation in Trial Master File
  • Supporting the COA Manager with COA research to determine appropriate copyright holder and establish licensing requirements
  • Securing 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
  • Tracking and communicating licensing agreement status and serve as central point of contact for internal and external partners for licensing agreements in clinical trials
  • Reviewing licensing invoices for pass through costs in coordination with Clinical Study Lead and COA manager; and ensure payment of appropriate license fees is completed
  • Receiving and cataloging source documents (English and translations) as received from the license holders and translation vendors
  • Tracking and maintaining database of license holders, ensuring compliance with terms and conditions of relevant contracts
  • Providing support for problem resolution between licensing holder and Regeneron study team
  • Participating in Standard Operating Procedures (SOPs) revisions or departmental initiatives
  • Proactively recommending process improvement initiatives for the department
  • May require up to 25% travel
This role might be for your if:
You have the ability to acquire solid understanding of copyright law and licensing/permission requirements for COAs
You possess strong attention to detail, effective communication skills and robust organizational abilities
You are proactive and self-disciplined with the innate ability to manage and prioritize your work effectively
You have proven success recognizing project challenges, implementing action plans, and calling out risks in a timely manner
You have general knowledge and awareness of systems development processes
To be considered, you must have a Bachelor's degree and at least three years of proven experience or a minimum of seven years of relevant experience in lieu of a degree. Basic familiarity of clinical drug development is also preferred.

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.