Janssen Research & Development, LLC is currently recruiting for Clinical Research Associates located in Chesterbrook, Pennsylvania.

At Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world’s the most significant healthcare challenges. Our Corporate, Consumer Health, Medical Devices, and Pharmaceutical teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines. We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives. With a reach of more than a billion people every day, there’s no limit to the impact you can make here. Are you ready to reimagine healthcare?

Here, your career breakthroughs will change the future of health, in all the best ways. And you’ll change, too. You’ll be inspired, and you’ll inspire people across the world to change how they care for themselves and those they love. Amplify your impact. Join us!

As a Clinical Research Associate, you will perform in a matrix environment, including working with Site Managers (SM), Local Trial Managers (LTM), Clinical Trial Assistants as well as groups external to GCO as appropriate.  Develop understanding of pharmaceutical development, regulations, compliance, and patient safety.  Clinical Research Associate will learn the SM and LTM roles in depth through 6-month rotations in each role working closely with a mentor.

You will assist with providing operational oversight of protocols from start-up through database lock and closeout activities as described in GCO procedural documents by working closely with the Local Trial Manager. Through this partnership you will actively contribute to process improvement; training and mentoring of Clinical Trial Assistants, Site Managers and other LTMs. 

In this role you will also closely partner with the Clinical Trial Assistant, Local Trial Manager, Clinical Trial Manager and Global Trial Leader to ensure overall site management while performing trial related activities for assigned protocols. 

In this role you will gain knowledge of and support activities of the LTM and SM positions under the direct supervision of a Local Trial Manager/Site Manager, and/or Functional Manager.

Responsibilities (SM and LTM combined)

• Support feasibility activities including the implementation of any local criteria for site selection, consistent conduct of pre-trial assessment visits and follow-up.  Provides input into the country feasibility report and the recommendation of suitable sites for selection to participate in the trial.

• Supports activities related to site initiation and start-up, site monitoring, site management and site-study close-out according to internal SOPs. Supports local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget.

• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. Arranges for appropriate destruction of clinical supplies.

• Ensures that all Serious Adverse Events/Product Quality Complaints are reported within reporting timelines and documented as appropriate.  The SM will also ensure that they are consistent with all data collected and with the information in the source document.

• Contribute the drafting of country level documents.

• Support site staff training activities and accurate filing of documentation of training.

• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.

• Ensures site staff completes data entry and resolves queries within the expected timelines.

• Ensures accuracy, validity and completeness of data collected at trial sites

• Maintains and updates trial management systems (such as mCTMS, VTMF).  Uses management reports to analyze trial progress.

• Participates in the full documentation of trial related activities, in particular monitoring- confirmation letters/visit reports/follow-up letters and the upload into VTMF.

Qualifications:

• Must be authorized to work in the United States and not require sponsorship in the future.

• A Bachelors or Masters degree in health sciences or a related field

• Must have a graduation date of January 2022 to December 2022

• A GPA of 3.5 or higher

• U.S. Junior Military Officer (“JMO”) who has completed a government assignment that did not exceed six years (e.g., all branches of U.S. military in which candidates from the Army and Marines ranked no higher than Captain and those from the Navy ranked no higher than Lieutenant)

• Strong verbal and written communication and presentation skills 

• Affinity for learning new technology

• Expert proficiency with Word, Power Point, Excel

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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

Travel: Up to 25% travel during Site Manager rotation.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.