Ebony Watson Email & Phone Number

Chapel Hill, Nc, Us

Us

•Collect, track, and review site records•Assist in quality control audits of study documentation •Collect, track, and review site regulatory document•File study documents in house, or electronically to TMF system.•Maintain and assist project team with trial progress tracking by updating the Clinical Trial Management systems (CTMS), as needed•Run reports in CTMS and Trial Master File (TMF) and address queries•Track study supplies and coordinate shipments of supplies to and from sites as needed•Copies and distributes correspondence, internal documentation, CRFs, etc., as appropriate•Deliver internal and external study meeting minutes•Maintain, update and deliver weekly study trackers and reports•Submission and maintainence of TMF•Provide staff members with access to required systems and databases and maintain organization of team and study contact list.•Interact with sites, clients, vendors and internal study team members•Coordinate with CRAs while on site in regards to missing or required documents; site, staff, and patient updates, and query resolution. •Serve as backup contact of CRAs for study sites to convey project information, answer questions, and resolve site related issues.•Submit and receive Consents and Approvals to and from IRBs•Ensure site compliance in regard to study protocol(s), procedures, and pertinent guidelines•Monitor site performance and implement action plans for sites not meeting compliance•Remotely assist in monitoring subject data, SDV of eCRFs and serve as resource to study sites in resolving queries and data collection issues •Perform IVRS review and reconciliation, ensuring data is accurate and up to date•Submit new and revised FDA1572s to the study revision team to ensure the FDA1572 is updated and all necessary site staffs’ Financial Disclosure forms and GCP trainings are updated. •Perform quarterly reconciliation of FDA1572 and Financial Disclosure forms to ensure the TMF is up to date

Assist CRA(s) in preparing for monitoring site visits by reviewing protocol, ensuring regulatory compliance and tracking required documentation.Assist the CRA(s) in ensuring that research data is clean for international quality assurance audits.Perform a variety of administrative duties and project management.Provide quality control to ensure study data, corporate solutions, submissions, CRFs, and reports for accuracy.Assist CRA(s) in writing summary reports of compliance or violation of regulations.Maintain and manage travel receipts/expenses.Create and submit expense reports for all travel occurrences.

Maintain and monitor tracking systems and submissions of transportation jobs implemented into system database.Manage and dispatch work orders, messages, and information to and from nurses, physicians, transporters, and supervisors.Ensure timely and efficient movement of patients according to work orders and schedules.Manage incoming and outgoing calls regarding care and transportation of patients.Monitor personnel and equipment locations/utilization to coordinate service and schedules.Communicate with supervising personnel regarding questions, problems, and requests for transportation service.Provide friendly and professional interaction with patients and family members.Transport patients and specimens safely and efficiently according to hospital regulations and department policies and procedures.Assist nursing and ancillary personnel with the movement and preparation of patients for transportation within the facility.Clean and maintain equipment used for transporting patients and equipment.Safely use hospital transportation equipment (stretchers, wheelchairs, hospital beds).

Collected, reviewed, and filed clinical documents and reports.Archived contracts and study files.Reviewed study files for accuracy and completeness.Ensured accuracy of documentation in databases.

Maintained and managed study tracking information.Reviewed study files for completeness and accuracy.Maintained and tracked adverse events (AEs) and subject/drug compliance logs.Processed specimen samples (blood, urine, and buccal swabs). Labeled, packaged, and shipped samples to appropriate labs.Provided outbound calls to patients to gather and document follow-up study participation information.

Bachelor'S Degree, Psychology

Associate'S Degree, Clinical Trials Research