Samantha Womack Email & Phone Number

Durham, North Carolina, United States

Durham, North Carolina, United States

Durham, North Carolina, United States

· Prepare feasibility for site selection · Prepare documents required for initiation, monitoring, and close-out visits with study-sponsor monitors.· Reconciliation of research-related charges in Maestro.· Develop a new recruitment strategy for Duke Pulmonary Vascular Disease Center. · Recruit, screen, consent and enroll research subjects for studies in the Duke Pulmonary Vascular Disease Center. · Ensure that research personnel are current with required study specific training.· Coordinate research subject visits for studies in the Duke Pulmonary Vascular Disease center. · Monitor and communicate with subjects throughout the study for Pulmonary Vascular studies.· Develop, and maintain IND and IRB documentation and comply with regulatory requirements. · Independently create and prepare protocols for PI initiate studies that are NIH and/or DOD funded. Independently?· Confer with the Principal Investigator and study team regarding any study-related issues. · Create profile for research studies on clinicalttrial.gov.· Gather, Analysis, and input the reporting results clinicaltrial.gov · Develop, maintain, and inspect CRFs, source documents, data forms, images, and study files to ensure completeness.· Ensure that all studies comply with Pulmonary SOPs, sponsor contractual requirements, IRB, GCP, and applicable regulatory requirements.· Create, collect, and maintain subject study documentation. · Perform data entry and reconciliation for all Pulmonary related studies. · Develop, maintain, and update documentation for the Durham Veteran Affairs (VA) IRB. · Coordinate study drug orders with the IDS pharmacy. · Review and resolve Maestro and sponsor-related queries. · Submit and maintain appropriate study advertisement in accordance with Duke Policies.· Participate in Pulmonary Clinical Research meetings and Pulmonary Clinical Research Coordinators' meetings.· Keep abreast of clinical research policy updates by attending all related training.

Durham, North Carolina, United States

Oversee DIAL and 129-Xeon imaging related studies at Duke Offsite locations.· Ensure that all research personnel is current with required study-specific training.· Prepare documents required for initiation, monitoring and close out visits with study-sponsor monitors and Radiology RPM.· Reconciliation of research related charges in Maestro· Act as primary coordinator for all DIAL related studies and 129-Xenon lung imaging studies; provide trainingand guidance to additional study team coordinators on DIAL related studies.· Develop new recruitment strategy for all DIAL and 129-Xenon lung imaging related studies· Develop and maintain all IND applications for DIAL lung gas imaging project.· Assist in maintaining IND for Xenon lung imaging project· Recruit, screen, consent and enroll research subjects for all DIAL related studies and 129-Xenon lung imaging studies· Coordinate research subject visits for all DIAL related studies and 129-Xenon lung imaging studies· Monitor and communicate with subjects throughout the study for all DIAL studies and 129-Xenon lung imaging studies· Develop, maintain, and update IND and IRB documentation and comply with regulatory requirements.· Confer with the Principal Investigator and study team regarding any study related issues.· Develop, maintain and inspect CRFs, source documents, data forms, images, and study files to ensure completeness.· Ensure that all studies comply with DIAL and 129-Xenon Lung Imaging SOPs, sponsor contractual requirements, IRB, GCP, and applicable regulatory requirements.Create, collect and maintain subject study documentation.· Update and maintain FileMaker Pro databases and Confluence Wiki database.· Create study specific SOPs housed in Confluence Wiki database.· Participate in audits by study sponsors and other entities.· Assist DIAL management with DIAL related administrative duties.· Continuation of CRC I and CRC II duties

Durham, North Carolina

Durham, North Carolina

• Developed and Maintained the IND regulatory and study binder for lung gas imaging projects. • Maintain and update the subjects’ folders for all DIAL related studies. • Recruit and screen subjects for all DIAL related studies. • Consent and monitor subjects’ for all DIAL related studies.• Scheduling all subjects’ for DIAL related studies • Developed case report for all DIAL related studies.• Maintain and update IND and IRB documentation for principal investigator. • Ensure that IND and IRB documentation complies with regulatory requirement and Good Clinical Practice. • Confer with the Principal Investigator regarding IND documentation. • Maintain accurate records of all study specific files in accordance with Good Clinical Practice.• Inspect CRFs, data forms, source documentation, images, and study files to ensure completeness.• Ensure that all studies comply with standard operating procedure of the lab, sponsor, the institutional review board (IRB), Good Clinical Practice, and applicable regulatory requirements.• Update and maintain FileMaker Pro databases and Confluence (SOP) Wiki database.• Participates in Internal Quality Assure Process. • Assist DIAL management with DIAL related administrative duties. • Communication within and external to Duke University Medical Center (DUMC) • Support as primary coordinator for coordinator staff • Date entry for sponsor’s study and lung gas imaging project • Reconciliation for sponsor’s study and lung gas imaging project

Durham, North Carolina

• Maintain accurate records of all study specific files in accordance with Good Clinical Practices. • Inspect CRFs, data forms, source documentation, images, and study files to ensure completeness.• Ensure that study data complies with standard operating procedure of the lab, sponsor, the Institutional review board (IRB), Good Clinical Practice, and applicable regulatory requirements. • Update and maintain FileMaker Pro databases and Confluence (SOP) Wiki database.• Maintain and update IND documentation for principal investigator. • Ensure that IND documentation complies with regulatory requirement and Good Clinical Practices. • Confer with the principal investigator regarding IND documentation. • Perform imaging quality assurance in DIAL de-identification process for HIPAA compliance. • Specific example of independent activity:  Review sponsor protocols to identify imaging requirements.  Interact with coordinators in the context of DUMC sponsored clinical trials. Interface with Imaging CRO’s to resolve image data issues in DUMC sponsor clinical trials. Written the DIAL SOPs and guidelines: • The data conditioning and data de-identification for the clinical trials sent outside DUMC PHI. • Radiology protocol review documentations.• Sending the study data to imaging CROs. • Study-specific SOPs.• Study closeout.• Developed and maintained the DIAL IND regulatory and study binder for lung gas imaging project. • Developed case report for the IND.• Perform imaging analysis according to study-specific SOPs • Perform imaging quality assurance in DIAL de-identification process to ensure the eighteen personal identifiers are removed correctly for HIPPA compliance.

Surf City, North Carolina

• Assisted in purchasing in store products. • Prepared and assisted product promotion. • Trained new employees

Wilmington, North Carolina

• Performed data entry (Pre-entry, first and second pass). • Knowledgeable in O*C database, Query Direct, Direct Connect, and LiveLink (PPD Imaging Database).

Master Of Science (Ms), Clinical Research And Product Development With Concentration Regulatory Affairs And Compliance

Bachelor Of Science (B.S.), Clinical Research