Senior Financial Analyst - Clinical Trials

Vitalief is seeking a Senior Clinical Research Financial Analyst to manage clinical trial budgets. This full-time, 100% remote role involves preparing, maintaining, and negotiating budgets, performing prospective reimbursement analysis, and ensuring regulatory compliance. The analyst will collaborate with internal departments, sponsors, and investigators, and develop financial reports. Candidates should have 3-5 years of experience in healthcare financial records and clinical trial budget management, along with proficiency in relevant software and regulatory knowledge.

Must Have

• Prepare, maintain, and negotiate budgets related to clinical trial activities.
• Perform prospective reimbursement analysis according to CMS National Coverage Determination Decisions.
• Ensure clinical research billing and regulatory compliance.
• Develop and distribute monthly financial reports to senior leadership.
• Bachelor's Degree in Accounting, Finance, Business Administration or a related field.
• 3 to 5 years of experience in maintenance and review of budgetary and fiscal records in a healthcare environment.
• Experience managing Clinical Trials budgets is required.
• Working knowledge of CMS, DHHS, FDA, OHRP, NIH, OIG, HIPAA and IRB.
• Proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, PowerPoint and OnCore.

Good to Have

• Experience with clinical contracts.
• Budget development.
• Variance analysis.
• Research of financial data and transactions.
• Experience in clinical research administration.
• Knowledge of regulatory, financial and administrative requirements of third-party billing for clinical trials.
• Knowledge of accounting principles for research.
• Experience or training in clinical research budgeting, financial management and/or coding.
• Thorough working knowledge of regulatory requirements and Good Clinical Practices (GCP).

Perks & Benefits

• Actively contribute to clients' mission of advancing scientific discoveries.
• PEOPLE FIRST culture prioritizing personal and professional growth.
• Encouragement of innovation.
• 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
• Company paid life insurance.
• Company paid short / long term disability coverage.
• 401K retirement program.
• Robust healthcare plans to choose from.

WHY VITALIEF?

Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. We are seeking a talented and enthusiastic Senior Clinical Research Financial Analyst to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients mission to impact and save lives. Reasons to work for Vitalief:

• You can actively contribute to our clients mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
• Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
• We give everyone a seat at the table we encourage innovation.
• Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
• Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.

Salary Range: $80,000 to $105,000 annually depending on experience level. Work Location: 100% remote role; company location is New Brunswick, NJ. We are only seeking candidates that reside in the EST or CST zones. Job Responsibilities:

• Reporting to the Manager, Budget & Reimbursement, this financial analyst is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities.
• Performs prospective reimbursement analysis according to CMS National Coverage Determination Decisions and all applicable billing regulations, third party requirements, industry standards, etc.
• Works in conjunction with other departments of the firm, as well as representatives from other higher education institutions, sponsors, attorneys, governmental agencies, and principal investigators.
• Requests clinical trial budgets and contracts documents from sponsors and CROs.
• Reviews clinical trial protocols and develops internal budgets. Prepares clinical trial budget documents and memos. Determines whether each trial is a qualifying trial per CMS regulations, and assesses compliance with other regulatory requirements, including FDA and NIH guidelines.
• Negotiates budgets with sponsors, interfacing with various internal departments as needed.
• Facilitates clinical trial billing administrative start-up, insuring clinical research billing and regulatory compliance. Collaborate with Finance to coordinate documentation of each clinical trial account from the beginning of protocol submission to the end of the study utilizing OnCore CTMS system.
• Performs regular audits of clinical trials to ensure that billing is complete and accurate and to ensure that the research project, database or protocol is carried out as outlined.
• Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active clinical trials and research subjects.

Required Skills:

• Bachelors Degree in Accounting, Finance, Business Administration or a related field.
• 3 to 5 years of experience in the maintenance and review of budgetary and fiscal records including experience with computer-based accounting systems in a healthcare environment.
• Experience managing Clinical Trials budgets is required.
• Maintains working knowledge of CMS, DHHS, FDA, OHRP, NIH, OIG, HIPAA and IRB.
• Demonstrates excellent interpersonal, oral and written communication skills. Strong organizational and detail-oriented skills.
• Proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, PowerPoint and OnCore.
• Continuously displays can do attitude cross functionally to contribute to the overall customer service plan.
• Develops professional relationships will all customers and maintains professional composure and confidence during stressful situations.

Preferred Skills:

• Experience with clinical contracts, budget development, variance analysis and research of financial data and transactions.
• Experience in clinical research administration; knowledge of regulatory, financial and administrative requirements of third-party billing for clinical trials and accounting principles for research preferred.
• Experience or training in clinical research budgeting, financial management and/or coding.
• Maintains thorough working knowledge of regulatory requirements and Good Clinical Practices (GCP).

PHYSICAL DEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs. #LI-DNP