Regulatory, Contracts, and Budget Clinical Trials Manager

Job Overview
We are seeking a highly motivated and detail-oriented Regulatory, Contracts, and Budget Clinical Trials Manager to lead the oversight of clinical trial compliance, contractual negotiations, and financial management. This position will also oversee clinical research coordinators as needed.

• Pay will be negotiable depending on experience.

Job Summary

The Regulatory, Contracts, and Budget Clinical Trials Manager is responsible for overseeing the essential study start-up phase and ongoing administrative, regulatory, and financial management of clinical trials. This role acts as the primary liaison between Principal Investigators (PIs), Institutional Review Boards (IRBs), trial sponsors, Contract Research Organizations (CROs), and internal financial and legal departments.

The primary goal is to ensure that all regulatory approvals, Clinical Trial Agreements (CTAs), and study budgets are negotiated, finalized, and maintained in compliance with federal guidelines, Good Clinical Practice (GCP), and institutional policies.

Key Responsibilities

1. Regulatory Compliance & IRB Management

• Prepare, submit, and track initial IRB applications, protocol amendments, annual renewals, safety reports (SUSARs/SAEs), and study closure documents.
• Maintain Essential Regulatory Documents (Form FDA 1572, Delegation of Authority logs, Financial Disclosure Forms, CVs, and licenses)
• Ensure strict adherence to FDA regulations, ICH-GCP guidelines, HIPAA, and institutional SOPs.
• Coordinate site initiation visits (SIVs), sponsor monitoring visits, and regulatory audits.

2. Contract Review & Negotiation

• Review and draft Clinical Trial Agreements (CTAs), Non-Disclosure Agreements (NDAs)
• Ensure contract terms align with federal regulations and site operational capabilities.

3. Budgeting & Financial Management

• Analyze study protocols and Schedules of Assessment to construct detailed, line-item clinical trial budgets.
• Negotiate study budgets and start-up fees (IRB fees, pharmacy fees, lab processing, administrative costs) with sponsors and CROs.
• Monitor study accounts, issue invoices for milestone payments, process subject stipends, and perform financial close-outs for completed studies.

Required Qualifications & Experience

Education & Experience

• Experience: Minimum 2–4 years of direct experience in clinical trial regulatory coordination, budget development, or contract negotiations.
• Knowledge: Deep familiarity with FDA regulations (21 CFR Part 11, 50, 54, 56, 312, 812), ICH-GCP guidelines,

Certifications (Preferred)

• Certified Clinical Research Coordinator (CCRC - ACRP)
• Certified Clinical Research Professional (CCRP - SOCRA)
• Certified Research Administrator (CRA)

Key Competencies & Skills

• Negotiation Skills: Proven ability to negotiate complex financial terms with sponsors and CROs.
• Financial: Strong proficiency in Excel, financial reconciliation, and study budget forecasting.
• Attention to Detail: Meticulous oversight of complex regulatory files and protocol revisions
• Software Proficiency: Experience with CTMS, eTMF systems, IRB portals (Advarra, WCG), and Electronic Health Record (EHR) systems
• Communication: Excellent written and oral communication skills to interface effectively with principal investigators, sponsors, and research teams

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person