As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Fortrea's FSP team is hiring Site Budget & Contracts Specialists!
Home Based in USA
As part of a global team you will be responsible for preparing country site budgets and study financial appendices, assisting with the negotiation of site agreement budgets and financial exhibits of a certain complexity.
Responsibilities include:
Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets. Ensure CTAs are executed in a timely manner in order to meet expected timelines for study start-up. Liaise with the legal departments to ensure any content changes to the CTAs are mutually agreeable, and in accordance with client's legally approved standard agreement language. Participate in Study kick-off meetings to obtain necessary information required for effective CTA execution
Solid understanding of standard contract language to enable decision making pertaining to sections of CTAs when language modifications are proposed by external contract parties. If language is not compliant, discuss issues with legal and work with the legal department, sites, contractors or vendors to resolve them.
Generate site budgets based on final approved country budget in preparation for distribution to sites and following up with investigators. Research medical procedure costs using local or global database in order to provide accurate data for development of the site level budgets to allow Country Lead Monitors/Study Managers to calculate the latest average costs on procedures for their new studies.
Manage CTAs ensuring all changes to agreements and corresponding components are updated according to client’s legal standards and client Global SOPs.
Responsible to ensure annual review of all templates with the Legal department and Local Head of Monitoring and Site Management
Manage the contract tracking database, including coordination of timely updates with respect to CTA. Ensure accuracy of information and reconcile discrepancies between documents and the database. Responsible for posting of fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.
Process for each study, internal approval forms and other documents which are required to ensure compliance with the Internal Signatory Process and are also required for annual audits.
Ensure excellent communication and collaboration as point person among clinical trial site personnel (Investigator, Study Coordinator, Institution's Legal Counsel) client’s Head, Clinical Operations, Legal Counsel and Manager, Insurance, throughout the contract negotiation process.
Responsible for preparing for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation.
Negotiate Master Services Agreements (MSAs) with Institutions where Clinical Trials have been conducted and ensure they are reviewed prior to their renewal dates
Education:
Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education
Experience:
Experience in the healthcare field, pharmaceutical industry or clinical research preferred.
Pay Range: 85,000k – 95,000K USD
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
Applications will be accepted on an ongoing basis.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.
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