Cassandra Willis Email & Phone Number

Raleigh-Durham, North Carolina Area

• Responsible for providing site management and monitoring services in accordance with industry, ICH/GCP standards and federal regulations.• Served as primary contact for assigned sites.• Assessed the suitability of potential investigative sites by review of feasibility questionnaires, telephone screening interviews and pre-study site visits. • Provided assistance in the production of eCRF database build for the study. • Conducted study start-up activities, including ICF, clinical agreement and budget review and negotiations, collection and review of regulatory and study-specific required documents, assist sites with IRB submission, greenlight review and approval for shipment of investigational product. • Served as a mentor to less experienced In-House CRA staff.• Generated site visit confirmation and follow-up letters for site visits.• Completed study monitoring reports in a timely manner.

Cary, North Carolina

• Responsible for assisting with and ensuring the quality and integrity of data and additional study-related activities to support the efforts of study team members.• Completed on-site Interim Monitoring Visit responsibilities for an Investigator-initiated clinical trial program.• Thoroughly reviewed and completed 100% source document verification of subject data.• Documented observations from monitoring visit and action items via monitoring reports, confirmation and follow up letters within specified timelines.• Submitted weekly expense reports.• Conducted IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date.• Liaised with sponsor/medical monitor regarding clinical questions and study status. • Served as a mentor to less experienced CRA staff.• Served as primary contact for assigned sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites. • Monitored site performance and implement action plans for sites not meeting expectations, in conjunction with Lead CRA. • Managed sites to ensure subjects are complying with protocol requirements, study visits, and timelines.

Durham, North Carolina

• Served as the primary contact and company representative for sites on assigned studies.• Managed resources and timelines associated with all trial 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 trials• Maintained timely and effective communication among team members and site staff, through oral/written correspondence and ensures adequate documentation of each communication.• Supported patient enrollment at each assigned site via engagement of sites in study-wide patient recruitment programs, or through development of site-specific enrollment plans.

Raleigh-Durham, North Carolina Area

• Monitor Phase II-IV clinical trials. • Serve as the primary contact and company representative for sites on assigned studies.• Manage assigned sites via 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 the majority of 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.• 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.• Routinely anticipate, identify, and resolves potential issues, and implement corrective actions.• 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.• Perform remote data review of eCRFs, lab reports, and IWRS/IVRS systems 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 own 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 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 maintenance 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 site qualification, initiation, interim, motivational, and 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

• Assisted in the development and implementation of national and international clinical study protocols and operational plans in coordination with corporate objectives.• Conducted site visits in accordance with protocol specifications and regulatory guidelines.• 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 regulatory, ICH, GCP Guidelines.• Developed study documents, including informed consent forms, source documents, case report forms and instructions, site selection materials, procedural manuals, project newsletters, and other project-specific documents.• 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.

Raleigh-Durham, North Carolina Area

• Assisted Lead Clinical Support Specialist in the creation of trial specific forms such as checklists and work flow forms.• Assumed leadership role of study team in the absence of Lead Clinical Support Specialist.• Processed and reviewed regulatory documents, site contracts, and informed consents for IRB submission.• Negotiated and finalized site budgets and contracts.• Assisted in the preparation of investigator meetings.• Managed timelines and budgets.• Served as an assistant contact with investigators and supporting staff of assigned sites through weekly site management calls and written correspondence.• Performed a variety of technical database duties in support of multi-center clinical trials to ensure accuracy and validity of clinical trial data according to standard operating procedures and trial specific guidelines.• Ensured team members receive updated trial documentation and are kept informed of relevant project information.

Bachelors Of Administration, Healthcare Management

Public Health