The Clinical Operations summer intern will support activities specific to Study Start Up (i.e. assisting with feasibility, study template creation, etc). They will develop exposure to study start up process, best practices, and regulatory expectations. They will work under the supervision of one or more senior Clinical Operations personnel.

The intern will serve as an active member of an ongoing MacroGenics Clinical Study Team, for example participating in regular team meetings. This internship offers valuable hands-on experience in clinical trial startup processes and provides an opportunity to work closely with experienced professionals. The intern will experience how CRO partnerships and vendors are engaged by sponsor organizations like MacroGenics to carry out global studies. On this project, she/he will work under the supervision of a designated senior Clinical Operations staff member.

Responsibilities and Job Duties

• Solicit feedback from study team members to identify tasks associated with oversight of organization and maintenance of trial-related documentation and files. This would include but not be limited to:
• Assisting in the preparation of regulatory documents for trial initiation
• Supporting the development of essential trial documents
• Coordinating with cross-functional team members to ensure timely initiation of clinical trial activities
• Provide administrative support to clinical study teams.

Minimum Qualifications

Education, Certifications & Experience

Rising college sophomore/junior/senior pursuing a Bachelor’s degree, or higher, in a science or health-related field.

Knowledge, Skills and Abilities

• Great attention to detail
• Strong computer skills
• Prior experience with Microsoft Office products

Preferred Qualifications

• An interest in clinical operations and clinical research is preferred.