• Throughout the conceptual phase of the project, oversee (as applicable) with protocol development from a scientific, statistical, regulatory, and administrative perspective.
• Identifies, evaluates, and selects national/global sites for Clinical Trial participation.
• Works with the National/International Principal Investigator in order to identify Clinical Trial key collaborators and resources and assists these collaborators throughout the lifespan of the Clinical Trial.  These collaborators may include an independent Core Lab, Medical Safety Monitor(s), Biostatistician(s), Independent Randomization Reviewer(s), Radiologist(s), and any other applicable resources required by the Clinical Trial.
• With oversight from the Office of Contracts Management, facilitates the subcontracting process between Vanderbilt University and participating Clinical Trial sites.

·          Works with the National/International Principle Investigator to develop appropriate Clinical Trial committees and takes the lead in meeting the ongoing needs of assigned committees.   These committees may include a Data, Safety, and Monitoring Board; Steering Committee; Clinical Improvement Committee; and Trial Operational Committee.

·         Within the regulations of the FDA and other governing bodies, implements processes for proper trial coordination at participating centers and individualizes processes when necessary in order to ensure protocol compliance by accommodating unique workflows.

• Develops written, multicenter study plans including Standard Operating Procedures, Monitoring Plans, and Committee Charters in order to streamline clinical trial workflow, provide accountability, set milestones, and identify expectations in order to ensure the trial's overall success.

·         Troubleshoots recruitment problems, reporting problems and works with research coordinators and investigators at participating institutions to ensure compliance with project standards.

·         Familiarizes themselves with current trends in technology, market pressures, resources, and leverages relationships with key stakeholders within the research community in order to facilitate the project's success.  

·         Responsible for establishing consistent methods for study communication in an effort to keep project on track, foster collaboration, improve communication, and continually gather support from participating institutions.

• Actively demonstrates facilitative leadership to foster productive teamwork amongst Clinical Trial Site Investigators and their study staff, Clinical Trial collaborators, the Clinical Trial sponsor(s) and/or financial partners, applicable Clinical Trial committees, and the internal Clinical Trial team at Vanderbilt University Medical Center (which may include collaborators in Biostatistics, The Department of Medicine, the Section of Surgical Sciences, BioMedical Informatics, Office of Contracts Management, Office of Sponsored Programs, Finance, the Human Research Protection Program, etc.).

·         Uses the project's protocol to determine the content of the training materials, databases, data collection documents, monitoring plans, and other details that are trial specific.

• Creates, distributes, and updates (as necessary) all Clinical Trial training materials (i.e.,: videos, questionnaires, presentations, newsletters, etc.) for participating Clinical Trial sites.   May require travel to participating sites to conduct initial and/or ongoing training.
• Serves as a resource for developing the initial Clinical Trial Agreement/Contract between Vanderbilt University and the Clinical Trial sponsor(s).

·         Works directly with the Office of Sponsored Programs, Office of Contracts Management and with the appropriate contacts at outside institutions to ensure all applicable regulations are met during the initiation of the project.

• Performs ongoing regulatory review for participating Clinical Trial sites in order to maintain compliance with applicable local, state, and federal laws and best practices. 
• Oversees safety profile of the Clinical Trial by reviewing Serious Adverse Event reports, Protocol Deviations, and other unanticipated events that occur at Clinical Trial sites and ensures that events are reported to proper authorities in a timely manner.
• Oversees continued institutional approval and applicable amendments at participating Clinical Trial sites that involve Institutional Review Boards and/or outside Contracts and Grants Offices.
• Responsible for developing, amending, and maintaining electronic data-capture systems associated with all aspects of multicenter data collection and study workflow.

·         Oversees the electronic data-capture and may oversee a project specific hotline where participants can receive assistance with regulatory needs, system support, clinical questions and/or receive enrollment support.

• Oversees the incorporation of automatic triggers into electronic data-capture systems in order to highlight issues in current datasets and generates queries when questions arise regarding data accuracy for each participating Clinical Trial site. 
• Communicates with the National/Global Principal Investigator, Site Investigators, and/or Clinical Trial committee members as needed regarding the status of Clinical Trial data by running frequent reports in order to identify gaps.  Develops and implements corrective action plans in order to encourage accurate and complete datasets.
• Oversees the verification process for the electronic data submitted from national/global Clinical Trial sites which may also include the oversight of Clinical Research Data Specialists who directly interact with the trial's data.   Responsible for the oversight of the project's monitoring process where study data is compared to original source documentation in order to ensure data accuracy while incorporating applicable laws and guidance.  Travels to Clinical Trial sites as necessary in order to verify data accuracy. 
• Develops and incorporates centralized and local (i.e.,: on-site) data monitoring plans and methods in order to ensure that final trial data is accurate and complete before analysis and publication occur.
• Responsible for identifying, assigning, monitoring, and maintaining appropriate levels of internal and external user access to Clinical Trial related data and study materials.   

·         Develops standard processes for participating institutions surrounding the status of the project's current dataset, compliance records, safety profile, and fiscal activities.

·         Compiles data, reports, and outcome measures in order to develop reports and presentations for various trial committees and sponsors that are reflective of current and future financial, safety, compliance, and enrollment milestones .

• Organizes and/or attends committee meetings, collaborator meetings, and internal operational meetings related to the Clinical Trial (which may require travel).   

·         Ensures that participating Clinical Trial sites remain compliant with data submission and other applicable reporting criteria before payments are issued according to their individual subcontracts.  

·         Compiles data on trial activities, quality of reporting based on contractual terms, and compares this information when processing invoices from individual sites.

·         Works directly with the Principal Investigator, sponsors, and federal government to identify additional funding opportunities when needed.

• May assist in writing grant proposals based upon established guidelines.
• Tracks and monitors expenditures against budget.
• Oversees progress report submissions to funding source and/or Program Director.