Summary

Target RWE is searching for a Data Operations Intern to provide overall support to the Data Operations Team. As an intern, you will work in parallel with the Senior Clinical Operations Specialist on the Regulatory, Contracting and Budgeting Team. The team is responsible for overseeing the negotiation and administration processes for Target RWE’s site contracts and budgets. This includes supporting contract language, budgets, and related documents for Target RWE’s various research programs. The position will provide support and guidance for regulatory essential documentation in accordance with ICH/Good Clinical Practice (GCP) Guidelines, Code of Federal Regulations and company SOPs and requirements. Lastly, this role wi provide operational support to the Clinical Program and Business Development teams.

What You'll Do

• Manage and file essential documents.
• Compile and distribute Site Regulatory Binders.
• Set-up Trial Master File (TMF), TMF filing and maintain documents by reviewing for accuracy and appropriateness for filing.
• Investigator Site File reviews and technical quality control activities in order to maintain complete and current versions of all essential regulatory documents during the course of a study to ensure files are audit or FDA inspection ready.
• Coordinate Study Level Central IRB submissions via upload or email.
• Audit and update clinical tracking systems.
• Perform operational tasks to support clinical operations teams with study execution as needed.
• Perform other duties as assigned.

Education and Experience

A student pursuing a bachelor's or master's degree and interest or experience in clinical research. 0 - 2 years of relevant experience required. An equivalent combination of education and experience may be considered.

Knowledge, Skills & Abilities

Excellent skills in Microsoft Office Suite (in particular Microsoft Word, Excel, and Outlook)

Strong organizational and documentation skills. Excellent interpersonal and communication skills, oral and written, to communicate internally and externally.

Strong attention to detail. Ability to make good judgment calls that are aligned with Target RWE’s procedures and strategies for negotiating various research agreements. Ability to set priorities and work in a fast-paced, multi-study environment.

Total Rewards

The salary estimated for this position is $15 per hour if pursuing a bachelor's degree and $18 - $20 per hour if pursuing a master's degree. Compensation will vary depending on job-related knowledge, skills and experience. Actual compensation will be confirmed in writing at the time of offer.

Why Target RWE

• Fast-moving, high-growth, biotechnology company
• The opportunity to impact healthcare and improve peoples' quality of life
• Work remote / from home culture that is flexible and no-nonsense
• Smart and easy-going colleagues
• 401(K) with a company match