Job Description

The Clinical Operations Intern will be an integral part of the clinical development team. The full-time internship, based in Research Triangle Park, will support the team’s management of late-phase clinical trials. You will be part of a dynamic, fast-paced, growing team. This is an excellent opportunity for a recent graduate or soon to be graduate, to learn all aspects of clinical operations, from study start-up to close-out, site management, GCP guidelines/regulations, TMF processes, and much more.  The ideal candidate will use their outstanding organizational and communication skills to help successfully execute the company’s clinical trials. The experience you will gain in this role will build a strong foundation for a long career in biopharmaceuticals.

SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES

• Support the Clinical Operations team in the successful execution of assigned clinical trials from protocol concept to clinical trial report, complying with Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
• Set-up, update and maintain clinical trial-related trackers such as regulatory documents, trial master file, startup progress, screening/enrollment, and others as necessary
• Prepare, maintain, and archive trial master files
• Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) as applicable
• Assist study team with trial progress tracking
• Perform other duties as assigned

Qualifications null Additional Information

EDUCATION AND EXPERIENCE

• BS degree, or BS anticipated completion in 2020, in pharmaceutical sciences, chemistry, biochemistry, biology, or a similar field
• Prior internship or work experience in a clinical development area is preferred, but not required

KNOWLEDGE, SKILLS AND ABILITIES

• Highly organized and detail oriented while maintaining compliant documentation practices
• Ability to thrive in a multi-disciplinary team environment is essential for success
• Ability to engage in team activities, understand project goals, and take part in data interpretation
• Enthusiastic, reliable and demonstrates good time management skills
• Strong analytical thinker
• Strong communication skills