Rockville, Maryland, USA
43 days ago
Intern - Clinical Regulatory Compliance

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. 

MacroGenics is a bold, highly engaged, and diverse team driven by a passion for improving the lives of patients through innovative science. We are committed to an inclusive workplace built on trust and respect. We value and nurture strong connections with one another and foster collaborative relationships. We empower our people and drive personal accountability.  We encourage curiosity and embrace our entrepreneurial spirit.  We celebrate our successes and create a learning environment where all employees can thrive!

Summary of Position

The Clinical Operations Intern will work on trials that are expected to be in various stages of start up and participate as an active member of an ongoing Clinical Study team. The Director of Clinical Operations, will act as the mentor and hiring manager for this summer intern position. Consulting and training will also be provided by other Directors in Clinical Operations and Vice President of Regulatory Affairs.

Responsibilities and Job Duties

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.

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service. 

Equal Opportunity Employer/Veterans/Disabled

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.

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