Cassandra Willis Email & Phone Number

Chapel Hill, Nc, Us

Raleigh-Durham, North Carolina Area

• Monitor Phase II-IV clinical trials. • Serve as the primary contact and company representative for sites on assigned studies.• Assure compliance with applicable regulations, and guidelines, Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.• Manage assigned sites via outbound telephone calls, web-based tools and other communication tools to ensure compliance with the protocol requirements, study procedures and relevant guidelines.• Monitor site performance metrics and, independently, implement action plans for sites not meeting expectations.• Support patient enrollment at each assigned site via engagement of sites in study-wide patient recruitment programs, or through development of site-specific enrolment plans.• Maintain up-to-date information within the deployed Clinical Trial Management System (CTMS).• Ensure all assigned sites are trained on the study protocol, informed consent process, data collection requirements/data collection tools (e.g., Electronic Data Collection (EDC) systems, Interactive Voice/Web Response (IVR/IWR) systems, etc.), Serious Adverse Event (SAE) reporting requirements and patient-reported outcomes instruments, as applicable.• Routinely anticipate, identify, and resolve potential issues, and implement corrective actions.• Review eCRFs completed by sites and assists the site in resolving queries and/or other identified data collection issues.• Perform review of clinical data listings.• Complete and submit visit reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions.• Maintain awareness of key study performance indicators for sites, e.g. Telephone Communications Reports, patient enrolment, and SAEs/Endpoints. • Attend clinical monitoring staff meetings, project team and investigator meetings.

Greater Los Angeles Area

• Organized office operations and procedures for Site Management Organization.• Maintained clinical research staff are in compliance with Good Clinical Practice and applicable regulations through training and on-going SOP development.• Developed and implemented study coordinator trainings and procedures.• Created corporate and department SOPs and Work Process Documents.• Prepared and reviewed study related documents (i.e., informed consent, study tools, work process documents).• Assisted in the development and management of study budget and maintain it within financial goals.

Canton, Ohio Area

• Performed administrative and office management tasks for family owned construction and engineering firm.• Designed and implemented office policies.• Organized office operations and procedures.• Developed and implemented Employee Handbook and Ethics Code of Conduct.• Designed employee annual review and objectives documents.• Prepared bid matching and bid submissions to corporations and government agencies for contract awards.

Lexington, Kentucky Area

• Responsible for performing site management and monitoring project activities in accordance with GCP/ICH guidelines, FDA or other local regulatory requirements and policies and procedures. • Conducted on-site qualification, site initiation, site monitoring, and site close-out visits to assess protocol and regulatory compliance. • Reviewed site study and regulatory binders. • Conducted source document verification of eCRFs/CRFs against medical records. • Performed drug accountability and reconciliation. • Verified study data collected is accurate and valid. • Responsible for responding to audit findings. • Assisted sites in query resolution. • Completed trip reports, confirmation and follow up letters per SOPs and Site Monitoring Plan.• Provided clinical and technical expertise to the project team(s) to ensure integrity of the data and study specifications.• Conducted and documented weekly site management calls.• Notified sites of outstanding queries and provide clarification or assistance, if needed.• Assisted in the development of pre-study, initiation, interim, and close-out visit report templates for CRA team and corporate standard operating procedures and work documents for the Clinical Operations Department.• Provided study updates to project team and management.

Raleigh-Durham, North Carolina Area

• Conducted site visits in accordance with protocol specifications and regulatory guidelines.• Assisted in the development and implementation of national and international clinical study protocols and operational plans in coordination with corporate objectives.• Assisted in facilitating the development of clinical contracts by working closely with Legal, Finance, and Project Management to develop requests for proposals, review proposals, and provide input regarding costs.• Managed resources and timelines associated with all study start-up activities, including investigator agreements, utilization of central and local IRBs, regulatory documents, and drug shipment authorizations. Managed the identification, recruitment, and selection of investigators for planned studies.• Assisted in training site personnel and CRO study team, via investigator meetings and other protocol-specific training in accordance with FDA regulations and ICH, GCP Guidelines.• Developed study documents, including informed consent forms, source documents, site selection materials, procedural manuals, project newsletters, and other project-specific documents required for the conduct of assigned studies.• Ensured the appropriate and timely review and approval of enrollment status reports, monitoring site visit reports, expense reports, memos to file, telephone contact reports, and CRO documentation needed to provide appropriate regulatory and operational oversight for assigned studies.• Provided daily direction to CRO Project Managers as required to meet project timelines.• Coordinated the activities of personnel/vendors responsible for the distribution of documents, forms, supplies, equipment, initial drug shipment and laboratory supplies to ensure all materials needed to execute the study are available when needed.• Planned, implemented, and documented auditing activities on assigned projects.• Assisted in development of corporate standard operating procedures for R&D Department.