Clinical Operations Junior Associate

Job Description

Kenvue is currently recruiting for-

Clinical Operations Junior Associate (Open)

This position reports to the CLINICAL OPERATIONS ASSOCIATE SH EH and will be located in Fort Washington, PA.

Who We Are

At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s and BAND-AID® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here .

Role reports to- CLINICAL OPERATIONS ASSOCIATE SH EH

Location- Fort Washington, Kenvue is currently in the process of moving its Global Headquarters from Fort Washington, PA to Summit, NJ. This role is based in Summit, NJ but there may be a period of time during the transition that you must report to Fort Washington, PA .

Travel Requirement - 10%

What You Will Do

The Clinical Operations Junior Associate is responsible for test material handling to support startup, conduct, and closure of clinical studies, and report finalization in accordance with all applicable ICH/GCP guidelines, Company’s policies, procedures, guidelines and regulations. The Junior Associate will assist the Clinical Operations Lead (CORL)/Study Manager and other team members (as applicable) with test material handling and support study implementation, processes and procedures, being an integral part of the clinical process from study start-up to study closure.

Key Responsibilities

• Conduct study sample/test material preparation, receipt and transfer to/from local and regional teams/labs.
• Assist with preparation of study material release process for quality review.
• Liaise with Clinical Supplies, Product Development and Quality departments to ensure test materials are approved for shipment.
• Perform study material disposition at the end of study including completion and filing of appropriate documentation.
• Track test material including receipt and transfer of test material to/from labs.
• Ensure overall compliance with study protocols, regulatory requirements, and ethical standards.
• Support team in ensuring that all Study Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs) and Special Situations (SSs) are reported within reporting timelines and documented appropriately.
• Collaborate with cross-functional teams to ensure timely and successful completion of clinical trials.
• Help to Identify and mitigate potential study risks and deviations.
• Maintain accurate and complete study documentation.
• Participate in study activities, including data collection, review and analysis.
• Ensure adherence to ethical principles and patient safety throughout the study.
• Stay up-to-date with industry trends and best practices in clinical trial management.
• Prepare study documents for archiving.
• Provide support to study team members and investigators as needed.
• Assist with set-up, maintenance and closure of Trial Master Files following data quality control procedures.
• Assist with organization of documents and trackers.
• Perform data Entry/data Verification in electronic systems along with any appropriate quality checks.
• Conduct general filing and document distribution.
  
  

What We Are Looking For

Experience and Skills-

Required Qualifications

• Bachelor's degree (in a related field preferred.)
• 1-2 years of experience in clinical trial management or related field.
• Excellent communication and interpersonal skills.
• Familiarity with regulatory requirements and guidelines for clinical trials.
• Ability to work independently and as part of a team.
• Attention to detail and ability to multitask in a fast-paced environment.
  
  

Desired Qualifications

• Knowledge of regulatory requirements and ethical standards for clinical trials.
• Proficiency in Microsoft Office and other relevant software.
• Experience with data collection and analysis.
• Demonstrated ability to problem-solve and make sound decisions.
  
  

What’s In It For You

• Competitive Total Rewards Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups
• Note- Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
  
  

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

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Experience and Skills-

Desired Qualifications

• Knowledge of regulatory requirements and ethical standards for clinical trials.
• Proficiency in Microsoft Office and other relevant software.
• Experience with data collection and analysis.
• Demonstrated ability to problem-solve and make sound decisions.
  
  

Primary Location

NA-US-Pennsylvania-Fort Washington

Job Function

R&D

Job Qualifications

What we are looking for