Research Specialist; Non-Clinical

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Day

Monday-Friday, Variable

9:00 AM

5:00 PM

Regular

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People first. Children always. Find your next career opportunity and make a difference doing what you love at Children’s.

Provides oversight for all aspects of clinical research occurring within a specified program. Develops, implements, and supports the research process at an expert level by assisting investigators in study design, completion of the approval process, and management of data. Provides guidance and assistance in protocol development, serving as back‑up coordinator to provide ongoing support for all trials in the specified program as needed.

Provides routine auditing/monitoring of ongoing trials for quality assurance purposes.

• 5 years of clinical research or 4 years of experience in clinical research with an advanced degree

• Advanced degree
• Experience in creating and negotiating study budgets.

• Bachelor’s degree in a scientific or health‑related field

• Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of exam eligibility
• Collaborative Institutional Training Initiative (CITI) within 30 days of employment

• Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi‑task and demonstrate strong organizational skills.
• Recognized as the Subject Matter Expert within clinical research processes and regulatory requirements.
• Knowledge of medical terminology.
• Working knowledge of applicable business systems including EPIC, CTMS, Microsoft Office, and Workday.
• Excellent project management skills with demonstrated ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Strong knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor
• Self‑directed and motivated to work independently toward short and long‑term goals
• Good written and oral communication, organization, problem‑solving, and interpersonal skills

• Provides training and assistance for research protocol development, conduct, and facilitation at an expert level.
• May oversee some financial tasks related to research and the Clinical Research Department, such as budget preparation and compliance to budget guidelines.
• Provides assistance with the grant application process for program‑specific grants and clinical research/trials in collaboration with appropriate personnel and ancillary departments.
• Collaborates with Research Administration to facilitate the pre‑award process, including contract and budget routing and feasibility review.
• Leads others in sponsor correspondence, monitoring, and study meetings.
• Analyzes the feasibility of establishing new research and/or institutional protocols.
• Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials in collaboration with appropriate personnel and ancillary departments.
• Provides leadership and expertise in study budgeting, sponsor interactions, budget and contract routing, feasibility assessments, account management, and reconciliation.
• Tracks research billing to ensure research procedures are billed appropriately and resolves invoice‑related issues with all parties involved.