Thomas Gravitt Email & Phone Number

Raleigh, Nc, Us

Raleigh, Nc, Us

New Bern, North Carolina, Us

Kinston, North Carolina, Us

Durham, North Carolina, Us

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• May provide assistance with design of study tools, documents and processes.
• Convey features and opportunities of study to site.
• Collaborate and liaise with study team members for project execution support as appropriate.

Durham, North Carolina, Us

• Performed site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.• Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.• Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Built awareness of features and opportunities of study to site.• Collaborated and liaised with study team members for project execution support as appropriate.

Raleigh, North Carolina, Us

• Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines• Assessed the qualification of potential investigative sites, initiated clinical trials at investigative sites, instructed site personnel on the proper conduct of clinical trials, and closed clinical trials at investigative sites• Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely• Provided regular site status information to team members, trial management, and updated trial management tools• Completed monitoring activity documents as required by PRA SOPs or other contractual obligations• Worked closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues• Escalated site and trial related issues per PRA SOPs, until identified issues are resolved or closed• Performed essential document site file reconciliation• Performed source document verification and query resolution• Assessed IP accountability, dispensation, and compliance at the investigative sites• Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines• Communicated with investigative sites• Updated applicable tracking systems• Ensured all required training is completed and documented• Served as observation visit leader• Facilitated audits and audit resolution

Raleigh, North Carolina, Us

• Recruited and evaluated potential sites for project participation, utilizing assessment tools and questionnaires to obtain project required information• Owned activation and management of assigned sites to ensure adherence to protocol design and proactively coordinated and drove completion of all requirements with urgency and professionalism including but not limited to coordinating all process contributors, escalating status and risks with mitigation plans, leveraging tools and dashboards to monitor timeliness and quality of activation critical path, and meeting high quality documentation requirements• Performed essential document collection, review, maintenance, submission, notification, and closeout activities, including but not limited to informed consent form (ICF) template(s), ensuring client and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines, and PRA SOPs• Performed project tracking to ensure clinical and site management information, including but not limited to project files, site contacts, client communications, and training assignments, are current, accurate, complete, and audit ready• Liaised with internal and external stakeholders to meet project specific goals, prepared for and participated in investigator and client meetings as necessary, escalated project and site related issues per PRA SOPs, ensured client and investigator obligations are being met and are compliant with local regulatory requirements and ICH-GCP guidelines• Managed additional clinical operations and project management tasks as required and outlined in job task list

Raleigh, North Carolina, Us

• Performed investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools to for use in evaluating investigative sites• Performed essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines• Supported investigators and investigative staff in fulfilling obligations with regard to submission according to local regulatory and IRB/EC requirements• Documented site and client contact and study interactions in a timely and professional manner.• Assisted site and team members with resolution of investigational site/data queries• Liaise with project team members regarding study site issues• Worked on multiple studies with a broad range of therapeutic areas, including contraception and oncology

Raleigh, North Carolina, Us

• Managed the production of proposals, on average 3 – 4 per week, for clinical research trials based on client's requests for proposals (RFPs) which vary in complexity and monetary value• Distributed and communicate estimate materials within defined deadlines• Applied strong attention to detail within RFPs making sure the client's specifications are assessed• Collaborated with proposal development team to ensure essential bid information is accurate, complete, and integrated into the bidding system• Coordinated meetings with business development, proposals, therapeutic experts, and other functional PRA business areas to gather information in order to complete the proposal• Communicated with proposal development team to ensure all comments and edits are incorporated before the proposal document(s) are finalized• Assembled project assumptions and create budget estimates• Identified problems that would put the proposal at risk and suggest resolutions with support

Chicago, Il, Us

OverviewCoordinate Allscripts software upgrades with client upgrade teams by developing an effective working relationship through conference calls and correspondence - always aiming to enhance the client experience.GoalAchieve all defined project objectives and milestones on schedule and with available resources through efficient planning, active monitoring, and effective communication.Responsibilities• Ensuring, validating, and approving weekly time entry for project team members• Developing forecasts, project plans, project charters, schedules/agendas, issues lists, and milestones• Demonstrating project control to clients through effective documentation, measurement, and reporting• Communicating challenges/issues to clients during upgrades by assessing causes and implications• Recommending solutions while encouraging collaboration and shared problem solving• Accomplishing all of these tasks with a high degree of independenceSoftware UseSalesforce | Oracle | Clarity | Microsoft SharePoint | Microsoft Project | Microsoft Office

Winston-Salem, Nc, Us

• Assist in developing and maintaining treatment schedules for 100, D-1, ACC athletes• Serve as one of eight trainers during the Fall of 2013• Gained problem solving skills by having to quickly address a variety of physiological issues, such sprained ankles, ACL injuries, and tendonitis• Establish relationships with 100 athletes in order to better their recovery period• Develop teamwork skills by working and collaborating with eight fellow trainers

Winston-Salem, Nc, Us

• Each summer from 2010 - 2013• Managed data while taking inventory of daily shipments of hundreds of new books• Supervised three other summer employees to make sure they were performing correctly• Regularly trained three new summer employees in procedures for receiving, unpacking, and organizing thousands of books• Reported daily progress to management to inquire project success

Winston-Salem, Nc, Us

• Meticulously collected data through observing each participant• Analyzed data concerning respiratory sinus arrhythmia when someone learns of unfavorable news• Adhered to strict schedule while performing the research

Atlanta, Ga, Us

• Each December in 2010 and 2011• Analyzed each package to make sure it was delivered to correct location• Cooperated with driver to reduce delivery time for each package• Quickly learned correct procedures to use while on the job