As a summer intern in the Clinical Project Scientist role, you will be a member of a clinical team dedicated to the development and execution of clinical strategies; and the clinical and operational implementation of a complex compound program in Phase 1 – 3 oncology studies. The role contributes to a cross-functional trial team developing a molecular entity, the clinical trial protocol, clinical trial materials, coordinating completion of clinical study reports and providing support (as needed) for preparation of relevant documents for regulatory filings. The Clinical Scientist intern will collaborate with the Study Responsible Scientist (i.e., Clinical Project Scientist) and the Study Responsible Physician(s) in monitoring of clinical trial conduct. This role involves extensive team matrix interactions with colleagues from several different disciplines.

RESPONSIBILITIES MAY INCLUDE:

• Gaining overall understanding of clinical research and drug development including but not limited to Good Clinical Practices (GCPs), International Conference of Harmony (ICH) guidelines, and Standard Operating Procedures (SOPs)
• Assisting with management of trial activities including patient tracking through screening process, eligibility, and enrollment
• Assisting with document processing and management within the electronic master file (i.e., vTMF)
• Participating in department and team meetings
• Participating in cross-functional team and clinical team meetings
• Development of study training materials/documents
• Shadowing key clinical and or functional roles for learning/development opportunities
• Observing Site Initiation Visits (SIVs)
• Supporting Clinical Operations during trial set up, conduct and close out
• Assisting with review of clinical data and query resolution
• Assisting with interpretation, reporting, and preparation of oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
• Review of medical literature and related new technologies
• Other projects as assigned

QUALIFICATIONS

• Undergraduate college students with completion of a minimum of four semesters
• Currently enrolled in a biology, chemistry, pre-med, or nursing program
• Graduate students must be pursuing a master’s or PhD degree
• Must have a minimum cumulative GPA of 3.0
• Fluent in written and spoken English
• Working knowledge of the use of Microsoft suite of software products including Excel and Word

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.