Clinical Trial Budget Specialist

Adaptive Research Inc. is driven to disrupt the CLINICAL TRIAL landscape in the United States. We believe that CLINICAL TRIALs should be accessible to all people and that research should reflect the diversity of people with certain health conditions. Our network is the key to faster, widely available CLINICAL TRIALs in community practices. We offer on-site clinical research personnel, standardized clinical operating procedures, trial management software, and regulatory support. We aim to improve the physician and patient experience while delivering the highest quality research data efficiently.

We are starting to make our mark and looking for a person with CLINICAL TRIAL BUDGETing experience to help us grow and achieve our mission. This is a part-time, remote (U.S. based only) consulting/contract opportunity. Depending on study volume, hours may range up to 15 hours per week. If you have some time and are interested, please read on.

CLINICAL TRIAL BUDGET SPECIALIST

• Develop and negotiate Excel-based CLINICAL TRIAL BUDGETs with trial sponsors and Adaptive Research affiliated sites that are conducting the studies, with a goal of providing an initial proposed budget to the sponsor within ten days after receipt of information from the sponsor.
• Perform a comprehensive review and analysis of CLINICAL TRIAL protocols and other study documents, including the research study budget, contract, informed consent, pharmacy and lab manuals and other supporting documentation.
• Sponsor budgets; Identify CPT codes for subject-related costs, including Investigator and staff time and procedures. Use sources such as Medicare websites to price services and procedures.
• Determine other invoiceable costs such as study startup and closeout costs, protocol amendments, subject reconsent, monitoring fees, patient stipends, and staff travel and mileage.
• Site budgets; Identify work to be performed by the site investigator and personnel, develop site budgets, and recommend site payment terms.
• Attend occasional virtual meetings and calls with sponsors, investigators, study coordinators, and Adaptive Research, to confirm study requirements, address budget questions, and negotiate budgets and payment terms.
• As requested, meet with Adaptive Research Accountants to discuss questions regarding budgets.
• Assist in developing standard fee schedules.
• May assist in building a CLINICAL TRIAL schedule of events in the CLINICAL TRIAL management system.
• Coverage Analysis; Perform a detailed coverage analysis of research procedures in alignment with CMS rules. Assist investigators in determining study status under Medicare coverage rules and in identifying services as non-covered research-only, routine care, investigational items and services along with tier associated costs.

Minimum Qualifications

• A Bachelor’s degree in healthcare administration, science, business or a related field.
• Requires a minimum of three (3) years’ related experience with coverage analysis and CLINICAL TRIAL BUDGETing.
• Coverage analysis certification such as ACRP and/or SOCRA credentialing (CCRS, CCRP) is preferred.

Knowledge, Skills, and Abilities

• Requires excellent communication, organization, analytical, and Excel skills, including use of “sumif” formulas, and experience developing advanced spreadsheets.
• Able to identify CPT codes for study procedures and visits, then price procedures based on Medicare websites and/or other sources.
• Requires a sense of urgency to complete budget estimates promptly.
• Must maintain confidentiality.
• Experience building budgets in a Clinical Trial Management System (CTMS) such as CRIO is preferred.
• Prior experience in Accounting and/or Finance.
• Prior experience as research study coordinator or financial specialist in a healthcare setting.

Job Type: Contract

Experience level:

• 3 years

Medical specialties:

• Neurology
• Oncology

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• CLINICAL TRIAL BUDGETing: 3 years (Required)
• related budgeting experience with coverage analysis: 3 years (Required)

License/Certification:

• certification such as ACRP, SOCRA (CCRS, CCRP) (Preferred)

Work Location: Remote