Tara CRCP's Email Addresses & Phone Numbers

📖 Summary

I have acted as a subject matter expert in clinical site contract and budget negotiation, and how each functional group within the study develop process are integrated into this stage of a study start up, site performance and site relations. Between the contract management, grant development, and other requirements for site start up in a clinical study, I have been able broaden my knowledge base extensively, while discovering efficiencies across all functional areas involved, in order to produce the best results possible for the portion of the process for which I am responsible. I have had to handle all of legal, financial, regulatory, compliance, and project management issues that needed to reach resolutions, that were crucial to studies meeting milestones and other primary objectives. I have implemented my ideas on strategic planning, and other initiatives that have resulted in more efficient practices, cost savings, and better communication between stakeholders.Senior Contracts Specialist @ • Prepare Investigator site contracts, negotiate any requested changes based on business requirements, coordinate contract scope review with internal customers and work with Legal department to finalize contracts. • Manage site/vendor relationships and issue resolution of moderate to high complexity. • Track, manage and monitor all changes to study scope ensuring timely change order finalization and implementation. • Identify new best practices and contribute to continuous improvement • Member of cross-functional teams; lead mtgs. as appropriate and influence line functions • Updates tracking system with site contract and vendor data in an electronic library • Interact with internal customers; prioritize assignments • Responsible for making timely decisions & direction of outcomes. • Train & coach others in outsourcing processes and industry practices • Prepare study specific request for proposals (RFPs); manage and influence RFP process, facilitate vendor selection, competitive bidding negotiations, benchmarking and sourcing strategy for clinical spend category • Perform and manage activities associated with the development and execution of contracts with Contract Research Organizations (CRO) performing clinical trial services and other vendors as necessary. From September 2011 to Present (4 years 4 months) Contract Manager @ Within the Vendor Management Division of the Multichannel Management Department, support vendor operations to consolidate vendors, assess services provided by vendors, collect metrics, and perform cost/service analysis for vendors. Provide supporting materials for ultimate vendor selection in service category area based on ad hoc reporting and analysis. Managed RFP process for enterprise level service category; responsible for everything from drafting RFP , consolidating responses, creating scoring matrix, creating pricing matrix, comparison chart for capabilities, efficiencies, and innovations. Research and review vendor contracts, SOWs, SLAs, invoices and all other available documentation for vendors under contract review. Prepare comparative analysis highlighting terms, conditions, pricing structure, cost and other variables assist in negotiations. Take care of internal compliance requirements with vendors. From March 2010 to October 2011 (1 year 8 months) Business Operations Associate @ Plan and manage clinical trials at various stages of completion, ensuring that logistical details, enrollment, training needs, milestones, budgets and timelines are met. Maintain regulatory documentation, site enrollment logs, status reports, clinical tracking reports, screen failure logs, waiver logs, protocol deviation logs, drug shipment accountability and effectively communicate with the Sr. Manager, Clinical Operations and all other appropriate parties about project progress, issues and changes. From November 2009 to January 2010 (3 months) CRA/CONTRACTS MANAGER @ This position reports to the Director Clinical Research, Contributes to the design, plan, and implementation of clinical research projects, evaluates and analyzes clinical data, maintains a working knowledge of protocol-related specifics in order to serve as a resource to the investigative sites, may draft documents including informed consent forms, source documents, patient instruction guides, and case report forms,coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives maintains a high level of professional expertise through a familiarity of relevant clinical literature and participation in project team meetings, conducts clinical monitoring of field sites to supervise and coordinate clinical studies; also works with CROs, updates enrollment tracking and generates enrollment reports, Ensure CRO/Company communication is complete, accurate and timely.Monitor CRO activity and ensure compliance with standards and timelines. Provide clinical research expertise, site monitor leadership and management of clinical monitoring activities. Participate in site visits i.e. – troubleshooting, pre-study, initiation, interim, co-monitoring and study close-out. Provide assistance with financial aspects of clinical component of Project. This would include initial negotiations as well as day-to-day management of budget and actual. Manage relationships and vendor management. Serve as the central point of contact and effectively manage relationships between members of the trial teams, CROs, sites and third party vendors. Review critical trial documents (protocols, ICFs, CRFs, EDC, IVR specifications, etc) for completeness and accuracy and ensure compliance. Drafted scopes and budgets for new protocols.Created and managed vendor and investigator database.Reviewing, negotiating vendor and site proposals, budgets and contracts.Develop RFP, Vendor Selection, and Contracting Processes. Created RFP Template. From August 2009 to November 2009 (4 months) Contract Analyst - Investigator Division @ Responsible for all financial aspects involved in contracting sites for clinical study. Required to carefully analyze protocol and work with study team to develop worldwide budget template that will be customized for each region. Lead budget negotiations for each Individual site, while working with legal team until agreement can be finalized. Oversee and coordinate all activities relating to site needs, i.e. amendments, special needs etc. Initiate and lead global and regional kick off meetings with all relevant parties, as well weekly status meetings with team. Utilized Grants Manager for protocol budget developement and site contracting. Responsible for site fund reclamation in order to recapture lost funds. Handle budget develop for wide range of research from ECDC studies, all phases, but mostly hematology and oncology therapeutic areas. From January 2009 to May 2009 (5 months) Contract Analyst - Vendor Outsourcing @ Based on protocol request services required in study, responsible for selecting vendors based on the service category, geographical area, study size, previous experience, and pricing. Created. Requests for proposals for each vendor, and served as the liaison between clinical team and vendors throughout the proposal, bidding, negotiating, and final vendor selection pases of the outsourcing process. This selection process was done under strict timelines, and required extensive Coordination and attention to detail in order to aide clinical teams in making appropriate choices for their particular project needs. Critical evaluation of proposals, and bid defense presentations from vendors necessary in selecting vendors possessing the necessary capabilities, and the lowest possible costs to the study budget. \ Served as Relationship Analyst for Vendors, role was to resolve any escalating situation with remediation action plan in order to bring about solution. From August 2007 to January 2009 (1 year 6 months) Contracts and Finance Specialist @ Dealt with third party vendors including accepting,negotiating vendor bids, implemented competitive strategies to allow for approval for clinical research funding. Outsourced to other necessary third parties for services in order to efficiently allocate funds. Created budgetsand negotiated all studybudgets.Worked with general counsel, directors of finance, research development, and risk management to ensure the successful initiation study. Reviewed, negotiated, and executed all necessary agreements/contracts needed for individual studies. Maintained and organized all documents, correspondences, executed agreements, bid versions. Worked hand-in-hand with Project Managers to design protocols to optimize time, location, and subject population, preventable or foreseeable expenses. Created RFP's and RFA's providing all relevant information on the proposed third party, or CRO, including my recommendations. From July 2006 to April 2007 (10 months) Clinical Liaison @ Developing SOP's for internal practices to improve efficiency and interoffice communications. Maintance of detailed project trackers. Created contract templates for large studies including site-specific changes.Internal Auditing position, verify source documents and regulatory documents needed for study.Tracked and verified patient payments and visits to study sites thru specific software.Intiated IRB and FDA submissions. Internal auditing, and monitoring.Created Web based e-learning application for GCP Certification. Created web site material. Coordinated Web Conferences to share information from sponsor and address and questions from sites. Participant the NIH Road Map/Intertrial Grant Study Team. Contributed to publications, updates, and reports on study team's progress. Deployed Clinical Website and its applications at study sites. From August 2004 to December 2005 (1 year 5 months) Senior Projects Officer @ Reviewed, Revised, Negotiated contracts and budgets for non-profit academic organization. Worked extensively with sponsor and investigator-initiated studies of all phases, wide range of therapeutic areas, Registry, device trials, International research, NIH grants and subcontracts. Confidentiality agreements, amendments, addendums, Master Agreements, Letters of Indemnification, Informed consents /assents, Risk assessments, FDA Submissions, IND/NDA Submissions and Foundation Studies. Drafted, Reviewed, and Negotiated Budgets .Responsible internal file maintenance on each Clinical Trial, including all documentation, electronic correspondences, and a detailed database which logged daily activity on each project. Ensured all Institutional, Industrial, Federal, and Ethical (i.e. GCP) requirements, standards of practice, and regulations are adhered to in contractual or otherwise during the process of initiating each trial to ensure compliance with all Institutional policies. From August 2004 to December 2005 (1 year 5 months) Bachelor's Degree, Biology/Biological Sciences, General, 3.4 @ University of Scranton From 2000 to 2004 Certification, Paralegal @ Hunter College From 2005 to 2005 Bachelor of Science, Biology @ UNSW Australia From 2002 to 2003 Highschool Diploma, NA @ Academy of the Holy Angels From 1996 to 2000 Tara CRCP is skilled in: Clinical Trials, CRO, GCP, Clinical Budgets, Contracts, Pharmaceutical Industry, Biotechnology, Clinical Research, Sop, Oncology, Negotiation, Lifesciences, FDA, EDC, Clinical Monitoring