Whitney E. Email & Phone Number

Raleigh, Nc, Us

Redmond, Washington, United States

● Develop and distribute meeting agendas, minutes and monthly status reports to documentkey project updates and communications to relevant stakeholders, as requested.● Participate in regular team meetings / teleconferences; CRO, Vendor and Investigator Sitemeetings as necessary; and Investigator Meetings, as necessary.● Support Clinical Project Management team in communication to CRO, Vendors andInvestigator Sites.● Support the Clinical Project Management team with study start-up activities, to includepreparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, study logs and forms Site Contracts and Budgets, Vendor Contracts and Budgets, etc.).● Support the Clinical Project Management team in the tracking of subject recruitment at all study sites; monitoring visits and approval; infringements, breaches, and misconduct, fraud, and negative trends and protocol deviations. Notify CRO and sites of updates on global study information.● Assist Clinical Project Management team in the collection, review and filing of site Essential Documents, and maintenance of the TMF.● Assist in the tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS as needed. ● Support the Clinical Project Management team in formal risk assessment activities; review and corrective action plans across study, participate in the planning of quality assurance activities, internal and external audits/inspections, and coordinate communication of audit/inspection findings.● Communication and support Clinical Project Management team with cross-functional study team interaction.● Perform other duties as assigned

Raleigh, North Carolina, United States

● Manage Study Master File(s)● Documentation and collection of study contracts● Request and collect Regulatory Docs, FDF, CV, GCP and ML● Review and approval of subset documents in applicable databases● Process core study documents ( upload, assigning of attributes, filing, review and approvalof subset of documents in eTMF)● Ensure successful study start up● Direct communication with site personnel to collect core trial documents, including trainingdocuments● Assembly and distribution of study documents and mass communications (e.g. Manual ofOperations, Study Tools, Newsletters, Annual Reports)● Monitor and report project specific training compliances, for site and internal team.● Review Informed Consent Form and assist with IRB submission(s) and review of IRBdocumentation/Review and negotiate contracts and budgets.● Participate in study-specific meetings, teleconferences and training. Collaborate withcross-functional team members and study sites throughout all study phases.● Review and negotiate clinical site investigator contracts and budgets● Prepare and coordinate preparation of contractual documents and correspondence

Raleigh, North Carolina, United States

● Clerical Review and assist in the process in accordance with SOPs, incoming SeriousAdverse Event (SAE) forms, including site follow-up for resolution of data inquiries, assist in distribution of IND Safety Letters to investigators and tracking of necessary follow-up, report as appropriate.● Coordinates with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial. Assures currency of required clinical trial documents within Central Files(i.e., CVs, FDA 1572,Lab Certification, Financial Disclosure and normals, etc.) throughout the clinical trial. Maintenance of project specific regulatory documents inventory systems. Prepares investigator grant payment requests and corresponding cover letters for distribution to Sanofi-aventis Finance and Clinical Investigators.● Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolves payment inquiries from investigator sites.2 ● Assists CPL/CRA in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals.● Confirms site receipt of shipped IP, alerts responsible CPL whenever IP inventory requires review/re-order and assists with drug reconciliation.

Durham, North Carolina, United States

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.Assist with periodic review of study files for completeness.Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Durham, North Carolina, United States

Proactively build trusting relationships with patients, providers, or other stakeholders ensuring their best interests are met.Act as a patient advocate ensuring all existing barriers impeding a needed therapy are identified and necessary steps are taken to remove them.Manage and respond to incoming calls and determine how best to meet the needs of the customer.Provide oversight and guidance on the transfer of prescriptions based on their degrees of urgency to specialty pharmacies as appropriate.Assist with the training of new Patient Access Advocates.

Raleigh-Durham-Chapel Hill Area

Actively engage with patients both in home and over the phone.Building rapport relationships with patients and caregiversHelp patients understand the value of the Landmark program, and how best to use its services.Conduct surveys with patients Contribute valuable insights to weekly interdisciplinary team discussions. Utilize helpful community resources available to patients.

Fayetteville, North Carolina Metropolitan Area

Performs basic patient care Observes and reports abnormal occurrences or changes in patient condition. Cleans, stocks, and maintains supplies for the patient and the unit.

Fort Bragg, North Carolina, United States

Prepare patients for various examinations, procedures and medical treatments.Assist hospital staff during patient exams and various procedures.Collect and maintain patient records.Schedule patients for procedures and follow up appointments.

Burgaw, North Carolina, United States

Phlebotomy procedures Wound Care and Splinting Triage Patient CareCNA Functions

Wilmington, North Carolina, United States

Competently performs a variety of patient care activities to meet daily personal needs and comfort of the patient. Performs Nurse Aide I skills. Maintains and promotes customer satisfaction. Demonstrates standards of performance: ownership, teamwork, communication and compassion.