CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see each day. Since its beginning, the company has been advancing the industry by developing lenses backed by cutting-edge research and advanced materials and optics. CooperVision has become a trusted and reliable partner for eye care professionals and lens wearers around the world. Whether addressing common vision correction needs, such as astigmatism, or more challenging issues, such as irregular cornea and childhood myopia, CooperVision brings a refreshing perspective to vision care backed by the world's most complete line of spherical, toric, multifocal and specialty lenses, along with the broadest portfolio of products to treat childhood myopia.

What We’ll Offer You

At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture, fuel a deeply engaged, high performing organization. For more information, visit www.coopervision.com

Job Summary:

We are looking for a dynamic team player to join our Clinical Affairs team in the Specialty Eye Care (SEC) Division to be responsible for the coordination and administration of clinical studies to support our specialty contact lens brands. Under supervision of the Director, Global Clinical Affairs, coordinates protocol-related clinical study procedures and manages interactions with Clinical Research Organizations (CRO), research institutions and principal investigators, ensuring CooperVision's compliance with Good Clinical Practices, standard operating procedures (SOPs), and regulations on document control and study materials accountability.

What you will do:

• Ensure coordination between the US and overseas SEC teams for clinical studies, including study management, site management, study documentation and study product management.
• Works with CROs with study site identification and compensation plan for SEC clinical studies.
• Ensures compliance with Good Clinical Practices (GCP), SOPs, and applicable regulations with particular emphasis on document control, device accountability, and site monitoring.
• Coordinates with Regulatory to maintain complete and accurate records of all clinical study documentation.
• Establishes and maintains study folder to ensure complete and accurate records of all clinical study documentation.
• Organizes, distributes, tracks, files and archives all clinical study documentation including protocols, CRFs, clinical reports, product traceability, adverse event tracking and communications with institutional review board/ethics committee and clinical investigators, ensuring timely completion of milestones.
• Coordinates and manages the flow of documents and study materials between Sponsor and clinical sites related to the conduct of clinical trials.
• Manages site training and maintain agreements, site visit and training logs.
• Ensures robust interactions between Sponsor and study site personnel to prevent, address and resolve issues
• Manages Clinical Inventory, including sourcing/ordering, shipping, receiving, transfer, traceability and destruction of investigational and commercial products (medical devices) used in clinical studies.
• Coordinates small Sponsor in-house clinical studies (scheduling and enrolling subjects, preparing the CRFs, subject compensation and data entry).
• Coordinates, schedules and performs a program of clinical study monitoring, as appropriate, via remote or on-site document and data review to ensure study site compliance with GCP, SOPs, study protocols, and applicable regulations.
• Coordinates and documents all study related activities including, informed consent development, IRB/EC approval, study start-up, enrollment, data management and closeout.
• Performs required clinical study or administrative tasks as assigned by the clinical Director.
• Occasional travel US and International as required (<10%) to qualify or monitor clinical sites and clinical studies.

What you will bring: (skill sets needed to perform the job.)

Experience:

• Minimum 2 years’ experience in clinical research operations, previous experience as a Clinical Research Associate (CRA) preferred.
• Experience as liaison between the sponsor and sites in clinical trials.

Education:

• Bachelor’s or Associate’s degree, biological sciences or medical/scientific-related field (or equivalent experience) required.
• Clinical Research Coordinator (CRC) certification through ARCP desirable

Knowledge, Skills and Abilities:

• Excellent administrative and oversight skills
• Attention to detail, systematic and orientation toward careful meticulous work
• Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology
• Strong Excel database skills
• Medical and technical aptitude, knowledge in ophthalmic medical devices is desirable
• Well-organized with ability to multitask and adjust to changing priorities

Work Environment:

• Normal office environment in a professional setting
• Prolonged sitting in front of a computer

Our Benefits:

• As an employee of Cooper, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical/dental/vision insurance coverage, 401(k), paid time off for vacation, personal, sick and holidays, paid family leave and many other perks and benefits. Please visit us at( Benefits | CooperVision) to learn more about Coopervision and the benefits of becoming a member of our team.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $66,735 and $88,980 and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

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