Clinical Contracts Specialist

1 week ago

Plainsboro, United States System One Remote Work Freelance Full time

Site Contracts Specialist

Remote

Full time Position

The selected candidate will support successful clinical trials by negotiating budgets and contract payment terms with sites and investigators in accordance with all relevant regulations and policies.

Relationships:

  • Clinical Finance & Operations of North America Clinical Operations.

  • Has extensive interaction with clinical site personnel, including Principal Investigators, Study Coordinators, and Contract Administrators, at trial startup and as a key contact during trial execution.

  • Is a contributing member of study teams. Interacts frequently with Legal department.

  • Coordinates extensively with Clinical Finance & Operations Sr. Associates.

Essential Functions - Project Support:

  • Reviews clinical trial protocols and develops investigator cost per patient budgets and site contracts for North America (US and Canada) Clinical Operations.

  • Coordinates with Trial Managers to plan site contract negotiations in conjunction with trial startup targets.

  • Directly negotiates contracts with sites in accordance with established policies.

  • Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines. Escalates issues for approval as required.

  • Ensures compliance with the application and communication of all client policies and procedures.

  • Compiles key study information for tracking and trending and reports to Manager of Clinical Finance and Operations, and Trial Managers.

  • Independently researches complex legal and business issues in support of budget determination and negotiation, makes recommendations.

  • May support the maintenance of guidelines, training programs, policies and procedures related to Clinical Trial contracts and budgets

  • Provides project direction to Clinical Finance and Operations Sr. Associates

  • Serves a key role in establishing and maintaining effective site relations.

PROJECT SUPPORT:

  • Utilizes current systems to support budget development and reports, draws conclusions, and may make recommendations to the Trial Managers and Finance Managers in relation to budgets.

  • Participates in budget challenge meetings.

Team Coordination:

  • Accountable for compliance and quality of CATS reporting.

  • Active membership to local/global project teams.

  • Assists with ensuring that quality of performance is in accordance with departmental expectations for function.

  • Attends relevant team and department meetings, forums, conferences and scientific meetings, as necessary.

  • Identifies, leads, develops, supports and communicates functional, departmental or organizational initiatives.

  • Participates in cross-functional teams locally/globally to assure timely attainment of project milestones.

  • Provides support for the implementation of continuous improvement processes for role and/or function.

  • Responsible for conducting oneself in accordance with expectations as a project team member to ensure the success of a Matrix management structure.

  • Responsible to maintain focus for specific project activities within CTM priorities.

Requirements:

  • Bachelor's degree preferred

  • 3-5 years industry experience

  • Budget and contract experience.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible Full time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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