Clinical Research Budgets and Contracts Specialist

Clinical Research Budgets and Contracts Specialist

09 Dec 2024
North Carolina, Raleigh / durham / CH, 27601 Raleigh / durham / CH USA

Clinical Research Budgets and Contracts Specialist

The Budget and Contracts Specialist will be responsible for supporting a portfolio of work within the organization, including: negotiating clinical trial agreements for studies awarded to M3 Wake’s Clinical Research sitesnegotiating Confidentiality Agreements (CDAs), master CDAs or Non-Disclosure Agreements (NDAs)negotiating vendor services agreements (VSA) or Master Service Agreements (MSAs) with M3 Wake Research approved vendorsThe person in this role will work directly with the Vice President of Clinical Operations to understand and follow through on all contractual aspects of clinical research. This includes collaborating to prepare and review contracts, and implementing the approval, filing, and compliance processes. The Budget & Contracts Specialist is also responsible for the appropriate compensation procedures for select contracts.Essential Duties and Responsibilities:Assist with the creation, administration and overall management of M3 Wake Research site contracts and budget activitiesNegotiation and execution of site budgetNegotiation and execution of site contractManagement of budget and contract amendments driven by study protocol amendment and protocol addendaCompile and maintain a library of procedural costs to for budget developmentCompile and maintain library of contract terms from key customer accounts to facilitate more efficient contract negotiationsAccurate and timely tracking and reporting of contract and proposal data network wideSubmission of final deliverables in accurate and timely mannerAssist with the management of the negotiation process, proactively escalating issues or proposing solutions in order to expedite the processUse commercial, fiscal and budgetary skills to develop budgets that match the service offering while ensuring costs are accurate and justifiable including all variables requiredCreate payment terms to ensure cash neutrality and conform with company standardsLiaise, directly or indirectly with Sponsors and CROs representing the sites as it relates to contracts and budgetsWork closely with Business Development and study start-up team to ensure timely completion of start-up activities relating to budgets and contractsWork closely with site clinical staff to collect study details to facilitate budget developmentWork closely with internal finance team to assist as a resource for interpreting contractual language and budgets for billing and revenue recognitionWork closely with in house legal department to ensure proper and necessary language of contractsUnderstand and comply with procurements, legal and financial requirements and procedures

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