FSP Site Budget & Contracts Specialist

Fortrea; Durham (NC); Remote; USD 80,000 - 89,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

STD/LTD

401(k)

ESPP

PTO / FTO

Company bonus

Job summary

Fortrea is recruiting for Site Budget & Contracts Specialists to work remotely from the US or Canada. You will prepare CTAs, develop country site budgets, and assist with negotiating budgets and exhibits for complex studies.

Responsibilities include liaising with legal, generating budgets, tracking contracts, and ensuring compliance with internal SOPs and audits. Travel to client sites may be required, and a bachelor’s degree is required.

Qualifications

• Must have a Bachelor's degree or equivalent in science or business.
• Healthcare/pharma/clinical research experience preferred.
• Strong attention to detail and ability to work with legal teams across functions.

Responsibilities

• Prepare Clinical Trial Agreements (CTAs) using standard templates and information from contract sheets.
• Liaise with legal to ensure content changes comply with approved language.
• Generate site budgets based on final country budgets for distribution to sites and investigators.
• Manage changes to agreements and related components per SOPs and templates.
• Support internal audits with a complete paper trail for each site contract negotiation.
• Negotiate Master Services Agreements (MSAs) and ensure reviews before renewal dates.

Skills

Contract negotiation

Budgeting

Education

Bachelor's degree

Job description

Fortrea's FSP team is hiring Site Budget & Contracts Specialists!

Home Based in USAor Canada

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
• Solidunderstandingof standardcontractlanguage toenabledecision makingpertainingtosections of CTAswhen 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 basedonfinal approvedcountrybudgetinpreparation fordistribution tosites andfollowingupwith 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 andclient Global SOPs.
• Responsible to ensureannual reviewofalltemplateswiththeLegal departmentand Local Headof 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 foreachstudy,internalapprovalforms andother documents whichare requiredto ensure compliance with the Internal Signatory Process and are also required for annual audits.
• Ensureexcellentcommunicationandcollaborationas pointpersonamongclinical trial sitepersonnel(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.
• NegotiateMaster Services Agreements(MSAs)with InstitutionswhereClinical Trialshavebeenconductedandensuretheyare reviewed prior to their renewal dates

Education:

• Must have a Bachelors' degree or an equivalent scientific or commercial Higher Vocational education

Experience:

• Experienceinthe healthcare field, pharmaceutical industry or clinical research preferred.

Pay Range:

$80,000K- 89,000K USD - this range does not apply to candidates residing in Canada

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.

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.