Clinical Research Operations Specialist

Joulé; Pittsburgh (Allegheny County); Remote; USD 80,000 - 100,000; Full time

Job summary

An innovative organization is looking for a Clinical Research Operations Specialist to join their Office of Clinical Trials. This role is vital for ensuring fiscal integrity and fostering collaboration with key partners. The successful candidate will oversee budget applications, negotiate with sponsors, and ensure compliance with institutional standards. If you have a strong background in clinical trial operations and possess excellent negotiation skills, this opportunity offers a chance to make a significant impact in the clinical research field while working in a remote setting.

Qualifications

• Minimum 2 years of experience in clinical trial operations focusing on budgeting.
• MUST have at least a year of experience within OnCore.

Responsibilities

• Oversee application of budget charges to clinical studies.
• Lead negotiations with study sponsors regarding budgetary concerns.
• Maintain accurate records of all negotiations and agreements.

Skills

Budgeting

Contract Negotiation

Clinical Trial Operations

Communication Skills

Regulatory Guidelines Knowledge

Education

Bachelor's degree in finance

Advanced degree or certification in clinical research

Tools

OnCore

Clinical Trial Management Software

Financial Systems

Job description

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Job Title: Clinical Research Operations Specialist

Location: Remote

Type: 12-month contract to hire

Hourly rate: $32 to $40 an hr

Overview:

Our client is seeking a Clinical Research Operations Specialist who will be a critical member of their Office of Clinical Trials, responsible for ensuring fiscal integrity, collaboration with key partners, and consistency in the execution of clinical trial agreements. This position will oversee the application of budget charges to studies, negotiate with sponsors, and work closely with the Sponsored Projects Administration (SPA) contracts specialist.

Responsibilities:

• Apply appropriate budget charges to clinical studies in alignment with study requirements and institutional policies.
• Create the budget within OnCore.
• Lead negotiations with study sponsors regarding budgetary concerns, ensuring that the institution's interests are upheld while fostering positive sponsor relationships.
• Provide study teams with the option to utilize departmental resources or the central office's fee-for-service mechanism for budget negotiations after coverage analysis.
• Serve as the primary liaison between the Office of Clinical Trials and the contracts specialist within the SPA.
• Facilitate efficient and compliant clinical trial agreement negotiations.
• Ensure that all agreements are consistent with institutional standards and regulatory requirements.
• Regardless of whether support is sourced from the department or the central office, ensure that all tools, templates, and reporting structures utilized are consistent.
• Provide training and support to departmental and central office teams to ensure standardized practices and efficient budget negotiation processes.
• Continuously evaluate and update tools and templates based on feedback and changing regulations or institutional needs.
• Maintain accurate and comprehensive records of all negotiations, agreements, and related communications.
• Generate regular reports detailing the status of ongoing negotiations, finalized agreements, and any challenges faced.

Minimum Requirements:

• Bachelor's degree in finance, healthcare administration, or related field. Advanced degree or certification in clinical research preferred.
• Minimum of 2 years of experience in clinical trial operations, with a strong emphasis on budgeting and contract negotiations.
• MUST have at least a year of experience within OnCore.
• Familiarity with regulatory guidelines related to clinical trials and agreements.
• Strong negotiation skills and ability to communicate effectively with both internal teams and external sponsors.
• Proficient in clinical trial management software and financial systems.