Tanisha Beasley, Bs Email & Phone Number

Morrisville, Nc, Us

Princeton, New Jersey, Us

Key responsibilities included ensuring that all study related documents are tracked, filed, and reviewed. Managed the Clinical Operations budget for the project, and within scope. Developed strategy plans, and tools while managing the Clinical Operations team and project deliverables.

Princeton, New Jersey, Us

Durham, North Carolina, Us

Subject safety, and Data Integrity within Clinical Trials.

Durham, North Carolina, Us

Decentralized / Site Management

Raleigh, North Carolina, Us

Wilmington, Nc, Us

Coordinate and implement communication strategies to maintain effective relationship with site. Actively discuss the status of the study with the site. Inform the PI of any source document concerns, any significant and/or continuing deviations from GCP standards as well as the protocol. Review patient data and source documentation to assess the safety and efficacy of investigational products. Ensure the site responsibly conducts the trial according to the approved protocol, GCP and applicable regulatory requirements.Assure reported data completeness, accuracy, and integrity. Monitored sites in accordance with ICH guidelines, and Good Clinical Practices.Completion of monitoring visit reports as outlined in the monitoring planMaintain a good rapport with sites to effectively resolve site issues in a timely fashionReview essential documents throughout the trial to ensure sites are successfully managed.Assisted in the design of source documents and study worksheets.Assisted in the site selection process by confirming potential investigators qualifications, adequate resources, and the patient population to meet enrollment.Ensure the Informed Consent processes at the study site are followed according to ICH GCPConfirmed proper documentation of adverse events and accurate reporting of serious adverse events. Write queries for CRF discrepancies.Conducted all types of visits: Pre-Study, Site Initiation, Monitoring, Closeout, and Booster Visits.Provide accurate, effective and timely site visit reports and follow up letters.

Us

• Managed exclusively clinical trial projects from initial set-up through final closed data set/archiving• Primary contact for sponsor and CRO• Designed and presented lab trial procedures at investigator meetings• Organized project specific team meetings• Designed and maintained organizational tools to conduct the research study accurately in compliance with GCP • Ensured project deliverables met customer expectations.• Enhanced the efficiency of workflow in data collection and query resolution.• Designed and presented at investigator meetings.• Maintained close contact with sponsor and attended bi-weekly team meetings.• Managed database set-up for protocol.• Maintained data reports for client review• Coordinated internal training

• Worked directly with trial subjects, to deliver high quality data in accordance with ICH GCP guidelines.• Ensured compliance with protocol guidelines and requirements of regulatory documents.• Conferred with trial subjects to explain the purpose of study and obtain informed consent.• Recruited and scheduled subjects for study procedures.• Obtained and processed blood samples for lab analysis.

• Implemented protocol procedures in accordance with ICH GCP guidelines• Maintained source document files.• Assisted with trial procedures and the collection of blood for analysis• Identified, contacted, and recruited trial subjects.• Completed CRFs consistent with the source data.