MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
The Associate, Clinical Contracts and Budgets will be a critical team member supporting the negotiation of clinical trial agreements and site budgets on behalf of MCRA, an IQVIA Business sponsor clients engaged in clinical research of varying design and therapeutic areas.
Responsibilities and DutiesWork with outside counsel and sponsor counsel to develop clinical trial agreement templates and study budget templates for clinical trials of varying design and therapeutic areas.Collaborate with sponsor management and sponsor legal teams, as well as physicians, hospitals, institution legal counsel and MCRA, an IQVIA Business clinical team, to finalize contracts and budgets for clinical research on a daily basis across multiple studies of varying design, scope and therapeutic area.Monitor the business, financial and legal risk in contracts and related documents and communicate these risks to clinical trial study sponsors.Collaborate with compliance division to ensure budgets are aligned with fair market value. Ensure compliance with HIPAA regulations and requirements.Work with sponsor legal team and site legal team to identify acceptable alternative/fallback language for clinical trial agreements and relative sections of the subject informed consent form (ICF).Stay abreast of current trends in compliance, coding and reimbursement and their impact on clinical trial budgets through continuing education and coding forum reviews.Contribute to the development of ad hoc clinical trial reimbursement resources and site training on billing/reimbursement processes during clinical research.Assist clinical research sites with understanding the appropriate reimbursement pathways and processes during clinical research.Research salient regulatory issues impacting the conduct of clinical research, including Anti-Kickback, Sunshine Act, Medicare Secondary Payer statutes, etc. Work collaboratively with other MCRA , an IQVIA Business departments, including clinical, regulatory and compliance.Required Knowledge, Skills, and ExperienceEducation: Bachelor’s degree in a scientific discipline or health policy; JD preferred. Experience: 1-5 years’ experience in contract negotiations or health law policy. Strong attention to detail and the ability to work both individually and collaboratively within a multi-disciplinary team, as well as with external partners and vendors.Possesses strong written and verbal communication and presentation skills.Ability to comprehend technical medical language and dissect clinical research protocols. Strong research, analytical and problem-solving skills.Strong legal drafting skills.Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.PC/Technical skills- MS Office, Excel, Word, PowerPoint.Must be punctual, polished, and professional.Effective interpersonal skills: shows confidence with subject matter and “calm under pressure” approach and style.Strong professionalism with client and site relations and managing client relationships.Work environmentCollaborative with a strong team spirit.Interaction with peers, subordinates, and managers across various departments. Entitled to a work environment that is free from harassment.Travel requiredTravel (10-30%) is required for this role.NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
MCRA, an IQVIA business, is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
