Clinical Operations Associate

Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), is currently recruiting for:

Clinical Operations Associate

Clinical Study Management and Monitoring

This position reports into Associate Manager, Clinical Operations and is based at 199 Grandview Road, Skillman, NJ.

Who we are

At Kenvue, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands-including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID -are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers' hearts and homes.

Join us in shaping our future-and yours. Watch us here.

What will you do

The Clinical Operations Associate is responsible for leading the operational aspects and risk-based monitoring activities for clinical studies in support of oral care and topical adult and baby skincare product development and claims substantiation:

Key Responsibilities

• Lead all operational aspects of assigned clinical studies from protocol development through study report finalization in accordance with ICH GCP guidelines, company standard operating procedures, and local regulations.
• Collaborate with a cross-functional team on study design development
• Serve as lead for protocol development (based on a protocol synopsis created by the Study Director) in collaboration with internal and external stakeholders. This includes protocol creation, coordination of protocol reviews and approvals, finalization, and amendments, as needed.
• Participate in and coordinate the selection/evaluation/setup of external service providers (ESPs) (e.g., study sites, investigators, etc.) including execution of quality/security assessments, confidentiality agreements, healthcare compliance submissions, clinical trial agreements, and purchase orders, in cooperation with Healthcare Compliance, Quality & Compliance, Information Security Risk Management, and Contracting teams.
• Serve as the primary point of contact with selected ESPs and train site personnel on study-specific protocol procedures and overall general Kenvue requirements.
• Prepare and/or review/approve study-specific essential documents including informed consent forms (ICFs), training materials, source documents, case report forms (CRFs), statistical analysis plans, recruiting materials, etc. As needed, coordinate the translation of study-specific documents and the procurement of appropriate license agreements.
• Oversee preparation and clinical release of investigational and auxiliary products, including determining required quantities, approving clinical label copies, overseeing development of reference safety materials, and ensuring accountability and final disposition of the products.
• Ensure Sponsor oversight by monitoring the progress of studies and the performance of ESPs on a continual basis through review/preparation of monitoring plans/reports, ongoing communication with the ESPs, review of clinical listings and logs, and routing/resolution of queries.
• Ensure that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs), and Pregnancies are reported within required reporting timelines and documented/processed appropriately.
• Set-up and maintain the Trial Master File (TMF) in real time following internal procedures.
• Coordinate and lead clinical trial disclosures on public registries, as needed.
• Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.
• Contribute to the writing and review of Clinical Study Reports, ensuring they are written and approved within required timelines.
• Assist more senior Study Managers with above and/or additional tasks as needed for higher complexity studies.
• Conduct Qualification, Site Initiation, Interim Monitoring, and Close-Out visits according to risk-based monitoring plans on behalf of the North America Clinical Operations team (up to 10% travel within US and Canada).

What we are looking for

Required Qualifications

• Minimum of a bachelor's degree in science, nursing, or related fiel.
• Minimum 3 years of experience as a Clinical Research Associate/Monitor.
• Minimum 2 years of experience as an independent Sponsor Clinical Study Manager (or equivalent role) including, but not limited to, experience with development of protocol, informed consent form, and other essential documents.
• Excellent attention to detail.
• Good problem-solving and critical thinking skills.
• Excellent written and verbal communication and presentation skills, in English.
• Efficient, organized, and capable of prioritizing multiple tasks.
• Proficiency in ICH GCP and FDA regulations/guidelines.
• Proficiency in Microsoft applications including Outlook, Word, Excel, Teams, PowerPoint, and Adobe.
• Good interpersonal relationship skills and being able to work effectively in cross-functional teams both internally and externally to the organization.
• Willingness to adapt to changing priorities and assignments.
• Willingness to travel within US and Canada up to 10% of time.

 

Desired Qualifications

• CCRP or equivalent certification.
• Demonstrated working knowledge of cosmetic and monograph drug regulations.
• Experience with TMF Reference Model.

What's in it for you

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups
• On-Site Fitness Facilities

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $84,000 to $118,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis