Clinical Research Specialist

This position has been designated as safety sensitive and cannot be filled by a candidate who is a current user of medical marijuana.

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Work Shift:

Please see job description for details.

Time Type:

Full time

Department:

CC033020 Clinical Research Operations

Summary:

The Clinical Research Budget & Amendment Specialist plays a key role in ensuring clinical trials remain financially sound and operationally compliant throughout their lifecycle by managing protocol amendment review, budget negotiation, and ongoing budget maintenance within the clinical research administration team.

This position is primarily responsible for intake and review of protocol amendments, budget negotiation related to amendments, and ongoing budget updates to ensure appropriate cost coverage and alignment with study requirements. This position will build and update study protocols within OnCore and serve as a backup to the primary budget negotiator for new study intake and development.

The role works closely with the project manager supporting study administration and requires frequent communication with Principal Investigators, study teams, industry sponsors, IT, finance, legal, compliance, regulatory, and other stakeholders to validate budget accuracy, operational feasibility, and protocol alignment. The ideal candidate will possess a strong understanding of research finance, medical terminology, healthcare operations, and stakeholder engagement.

The successful candidate must be able to work effectively both as a collaborative team member, and as an independent contributor, successfully leading complex negotiations from initiation through execution.

Additional Information:

Set up clinical trial budgets and contracts for the clinical research program. Provide guidance and assistance to coordinators and investigators with financial management of the clinical trials and with the electronic clinical trial management system. Financially manage projects to include invoicing the sponsor, ensuring all costs are recorded to the project, verifying clinical trial billing compliance, and reviewing accounts on a regular basis.

Required Education:

High school diploma or GED or equivalent

Recommended Education:

Bachelor's degree in a related field of study.

Required Work Experience:

High School Diploma/GED, or 2 years of experience in lieu of a diploma/GED.

Recommended Work Experience:

Required Certifications:

Recommended Certifications:

Description

1. Ensure financial terms of clinical research agreements are carried out and responsible for the financial management of project accounts.

2. Set up each project in the electronic clinical trial management system and create a custom excel spreadsheet summarizing the clinical trial activities for the financial account review. Invoice for costs as directed by the sponsor contract and provided by the research coordinators that may include start-up fees, subject activity invoiceable items, storage and IRB fees, and other costs.

3. Monitor project expenses and revenue through the account review process and record them to appropriate project account. Review all accounts at least annually and upon closing. Coordinate project entries with AC Accounting to ensure expenses and revenues are recorded timely.

4. Maintain accounts receivable report for invoices generated and follow up with sponsors for payment. Confirm that payments received from sponsors are recorded to the correct account. The Clinical Trial Specialist will provide account information to AC Accounting and allocate costs for Facility and Administrative expenses (F&A).

5. Trains and assists research coordinators and investigators with the clinical research management system.

6. Performs other related duties as assigned.

7. Performs other related duties as assigned.