Business Operations Services Senior Analyst

Advarra is a research compliance company that provides institutional review board review, institutional bio-safety review, GxP and Human Research Protection Program consulting as well as integrated technology solutions to facilitate the conduct of research. Advarra’s client base is broad and includes pharmaceutical companies, biotech companies, institutions, hospitals as well as clinics and private physician offices.

Description

General Summary

Deliver clinical research services that enhance research effectiveness, study activation timelines, and billing compliance and which are both specific to the software applications (Clinical Trial Management System as well as Electronic Data Capture) of Advarra and are software agnostic.

Primary Duties and Responsibilities

• Service Delivery
  • Complete clinical research study site specific Medicare coverage analysis, coding, internal budgets and negotiate reimbursement with sponsors and CROs based on the internal budget and on behalf of customers.
  • Work closely with the Business Operations Services team, based in India, who will also complete site-specific internal budgets and Medicare coverage analyses.
  • Provide Quality Assurance oversight and collaborate on any required changes prior to delivering internal budgets and coverage analyses to the customer.
  • Act as a subject matter expert to ensure guidelines and builds are in accordance with the latest regulations and in alignment with the chosen industry certification provider.
  • Communicate with customers, including Clinical Trial Office administration, investigators and study teams, upon completion of services requiring communication.
  • Act as a liaison and escalation point for any requested changes or questions from customers.
  • Review, understand and apply information in clinical research protocols, Informed Consent Forms, Clinical Trial Agreements, and other relevant study-related documents when managing or conducting quality assurance.
  • Define processes for internal and external workflows to ensure quality and efficiency, and excellent customer communication; identify and lead continuous improvements to processes over time.
  • Ability to be flexible to collaborate internationally as required.
  • Perform other job-related duties as assigned.
• Account Management:
  • Act as primary point of contact for designated customers.
  • Lead customer kick-off calls as needed for introducing specific services.
  • Determine monthly workload related to each customer.
  • Maintain high level quality and customer SLAs for all services.

Position Requirements:

• 4+ years' work experience directly related in a clinical trials environment specific to the creation of Medicare coverage analysis, site specific internal budgets, and negotiating budgets directly with sponsors and CROs.
• Knowledge of FDA and Medicare regulations related to clinical trials is required.
• Coding experience is required, certification is preferred.
• Research, medical billing, clinical or healthcare compliance/auditing experience are preferred.
• Experience with Clinical Trial Management Systems preferred.
• Sound knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research.
• Knowledge of pharmaceutical industry regulations and Good Clinical Practice guidelines related to human research.
• Expected to work independently, as well as in a team environment.
• Excellent organizational and administrative abilities
• Ability to liaise with key stakeholders across the organization.
• Familiarity with MS Office and various business software.

Key Personal Attributes:

• Highly personable nature that fosters teamwork.
• Excellent communication skills – oral as well as written.
• High energy and positive attitude towards working in a culturally diverse environment.
• A passion for ensuring outstanding customer support with a solutions-oriented attitude.
• Proactive and takes ownership in all tasks from start-to-finish.

Working Hours:

• Monday-Friday 8:00 a.m. to 5:00 p.m.

Physical and Mental Requirements

• Sit or stand for extended periods of time at stationary workstation
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus
• This position requires regular oral/written interaction with clients, team members and management