Clinical Trial Specialist

Clinical Trial Specialist/Contract Operations CoordinatorKelly is looking for a long-term Clinical Trial Specialist with contracts experience in Titusville, NJ. This is a hybrid position where you would be in the office 3 days and 2 days remote. You will be eligible for full benefits including health, dental & vision insurance, 401K, paid holidays and paid time off.Summary:The Business and Contract Operations Coordinator will support the Business Strategy and Contract Operations Leaders in partnering with Medical Affairs and staff to drive the coordination of activities necessary to meet cross-Therapeutic Area research and operational objectives and timelines (e.g., Global concept and protocol reviews, HCC reviews, CPC documentation and support, contracting, budget tracking, etc.), including interacting with associated systems (Totality, Gensight PMT, Sharepoint, MS Teams, ReCAP, ICD, eMarketplace, Icertis, Aravo).This is a key coordinating role to ensure compliance with company and departmental policies and processes, primarily in support of at least one functional areas across Medical Affairs and other JSA departmental teams (i.e. DMI, VESE, CHME,MISE REMS, RW Indirect) contracting/procurement process and support, and health care compliance review.The individual will also assist with process development, system reviews and submissions, identification and resolution of system and process issues, financial budget tracking and reconciliations, and perform a variety of administrative tasks, including scheduling appointments and planning meetings.The function of this role includes a collaborative team environment to achieve a shared goal or outcome in an effective way.Responsibilities:This individual will be a key coordinator in ensuring all internal Scientific processes are carried out in accordance with policies and procedures, including but not limited to:Individual will support the End-to-End Contract process for at least one JSA and/or Medical Affair functional areas.This includes gathering required information from Study/Project Leads, completing eMarketplace contract requests, interacting with Procurement and Contract managers, and facilitating review of contract redlines.Review project proposals / SOWS / Change Orders to ensure accuracy in financial and contractual information. Coordinate Contract Execution with signatures from senior leadership.Business and Contract Operations Analyst will be knowledgeable in both RECAP Concept reviews and HCC Operational Support:RECAP Concept Operational Support: One on one interactions with Project Owners to submit project concepts for review.Track system approvals for downstream activity. Work with Project Managers to ensure Methods Review process is initiated as applicable.Position will have responsibility for all RECAP project entry for US groups but tracking of project reviews will be across the broader Americas RWE, HECOR, Med Affairs (in Canada and Latin America) for AMRB purposes.HCC Operational Support: Coordinate HCC review for non-CPC HCC projects, including gathering required information from Study/Project leads to complete required HCC documentation requirements, including creating Totality transaction, working with Finance to conclude on FairMarket value assumptions, interacting with JSA/MAF Healthcare Compliance Officer, and facilitating responses to requests for additional information.Support financial and budget tracking for JSA/MAF projects entered in Gensight PMT. Partner with finance to manage reconciliation of payments, budget reclasses, invoices, and purchase orders.Tasks include weekly reporting to JSA team on project status, updates to finance as required by the financial calendar for budget updates and financial closing activities, working with each project manager (~50) to adjust timing on project spend, working with suppliers on accrual templates and invoicing, ACREW quarterly Financial Accrual submissions.Partner with other Business Strategy and Operations team members to ensure alignment between financial and other milestones.Provide guidance to Study/Project Leads on company and departmental policies and processes.Acts as a resource for scientific staff to troubleshoot and solve issues in the above areas. Identify and recommend process improvements.Perform a variety of administrative tasks, including scheduling appointments and planning meetings.Education: Requires 4-year degree, no specifications on type of degree but should be in the healthcare industryA minimum of 1 year project management and process development experience, and a minimum of 3 years overall relevant experience in the Healthcare industry is required.Knowledge of healthcare compliance environment and budget management in Healthcare industry is preferred. Strong analytical, project management, and problem-solving abilities are preferred.

Created: 2025-03-03