Oncology Clinical Scientist Intern

Job Description
As a summer intern in the Clinical Scientist role, you will be a member of a clinical team dedicated to the research and development of oncologic therapeutics including, execution of clinical strategies; the clinical and operational implementation of complex compound programs in Phase I to III clinical oncology studies. The selected candidates will be assigned a mentor and will have the opportunity to contribute to clinical trials in our prostate cancer, solid tumors, and hematologic malignancies teams. This role involves extensive global team matrix interactions with colleagues from several different disciplines.
The Clinical Scientist intern may contribute to Cross-Functional Trial Team (CFTT) activities, including but not limited to developing the clinical trial protocol, clinical trial materials, literature searches and review, medical review of trial data, coordinating completion of clinical study reports and providing support (as needed) for preparation of relevant documents for regulatory filings. The intern may also collaborate with the Study Responsible Scientist (SRS), the Study Responsible Physician (SRP), and or other project teams in various functional disciplines in monitoring and or supporting various aspects of clinical trial conduct. Each intern will have their own or group assigned projects and will be expected to present their work to their project teams, the oncology Senior Leadership Team (SLT), and as a poster/abstract at the research symposium at the end of the internship.
The goal of this internship program is to provide undergraduate and graduate students experience in working in a large pharmaceutical R&D setting and to gain basic understanding of the science and process of novel drug development. Students will have the opportunity to learn aspects of cancer disease states, diagnosis, treatments, and the mechanism of action behind the emerging drugs being developed in in conduct of our clinical trials. Students will also receive detailed training on Standard Operating Procedures (SOPs) as part of the Clinical Scientist Intern curriculum, trial specific training, and the clinical database software and medical data review tool.
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, and eligibility/enrollment reviews
• 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 Team with study start up activities during trial set up, and other study tasks during conduct, and close out
• Assisting with review and cleaning of clinical data (i.e., medical review), query generation and 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, related products, and new technologies
• Collaboration and or assigned projects from other various functional disciplines
• Leadership opportunities on specific program and or group projects
• Abstract/poster preparation and presentation at organization-wide research symposium
• Other projects as assigned

Qualifications
Qualifications

• Legally/permanently authorized to work in the US with no required sponsorship.
• Must be currently enrolled in an accredited University or College program throughout the duration of the internship.
• Undergraduate college students with completion of a minimum of four semesters.
• Currently enrolled in a biology, cell/molecular biology, biochemistry, chemistry, pre-med, or nursing program, or similar areas of study.
• Graduate students must be pursuing a master's, PharmD or PhD degree.
• Must have a minimum cumulative GPA of 3.0, which is reflective of all college coursework.
• Self-motivated, passionate about drug development and clinical research.
• Proven leadership/participation with campus programs and/or service programs is desired.
• Fluent in written and spoken English.
• Great interpersonal, verbal and written communication and presentation skills.
• Good presentation skills; leading presentations to peers, project teams and senior leadership teams.
• Enthusiastic, collaborative, able to build relationships and work within global matrixed and cross-functional teams.
• Ability to work on and balance multiple project deliverables.
• Working knowledge and or experience using key Microsoft suite of business tools including but not limited to Outlook, Excel, PowerPoint, Word, Teams, Slack, SharePoint, OneNote, etc.