Starr Cook Email & Phone Number

Apex, Nc, Us

Apex, Nc, Us

Southborough, Massachusetts, Us

Eatontown, Nj, Us

• Responsible for leadership of CRAs.• Track monitoring metrics and monitoring deliverables.• Oversee and ensure training of all research monitors.• Work in conjunction with the Project Manager on monitoring strategy and monitoring schedule.• Performed monitoring visits and co-monitoring visits.• Review and approve monitoring reports.• Provides input and direction in develop Clinical Monitoring Plan• Review of study protocol and familiarity with all study procedures.• Conduct pre-study visits to determine site and investigator qualifications; preparation of reports based on pre-study visits.• Development of study documentation, including CRFs, study reference manual, tracking logs, and regulatory binder.• Conduct initiation visits with investigative site personnel, preparation of initiation visits report.• Serve as primary contact and resource for study sites. • Monitor site source documents, CRFs and/or EDC for accuracy, completeness, and compliance with GCP, ICH guidelines, and protocol requirements.• Maintain close communication with sites to track recruitment and enrollment.• Ensure that investigative sites have adequate clinical supplies to meet study needs.• Identifies areas in which resources or progress are not consistent with the project plan and in the formulation of corrective action plan.• Communicate up-to-date information regarding study progress to all relevant parties.• Responsible for study close-out visit and follow up on data query resolution.• Attendance at Investigator Meetings as needed, attendance at other meetings with sponsors or their agents as needed.• Contribute to training activities for team members or investigative sites.• Participate in clinical training programs and maintain awareness of developments in the field of clinical research.• Other clinical research duties as required.

South Jordan, Utah, Us

• Management of clinical research monitors, including but not limited to, trending and tracking of monitoring deliverables, monitoring metrics, review and approve monitoring visit and other trip reports, and recommend potential solutions to identified issues to ensure adherence to monitoring plan protocols, e.g., monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates. • Reviews and approves research monitors time and expenses.• Oversee site qualifications, study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities to assure protocol requirements, regulatory guidelines and study timelines are met.• Monitors site performance by review of site data quality trends and data review including queries and protocol deviations. • Prepare and/or assist in the production of all documents, including individual study monitoring templates, necessary to oversee the clinical activity implementation, monitoring and reporting in a high quality and timely manner (such as monitoring oversight plan and clinical monitoring metrics). • Co-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites, identifying, and solving issues in study progress, verifying data in-house or by conducting co-monitoring visits, in collaboration with other study team members.• Conduct quality assessment visits with other monitors to assess quality of monitoring activity and compliance.

• Provide GCP and project training to site staff.• Assist in development of associated study documents (Safety Monitoring Plans, Manual • Provides GCP and project training to site staff. • Assists in development of associated study documents (Safety Monitoring Plans, Manual of Operations and Informed Consents).• Identifies site issues/problems, and associated root causes, and develops action plans to ensure resolution, including escalation of appropriate issues in a timely manner. • Acts as the main line of communication between the site and project manager.• Leads study start up team as needed. Provides support and acts as primary point of contact for collection and review of site essential documents.• Manages study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations. • Conducts monitoring visits (Qualification, Site Initiation, Interim, Close-out, Audit Prep). • Generates clinical monitoring reports and follow up letters in a timely manner.• Verifies that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study. • Verifies that the investigator and research staff follow the approved protocol and all GCP procedures. • Communicates deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensures corrective action is implemented.• Reviews queries and assists in resolution. • Utilizes CTMS to generate, review and provide study reports. • Assists with setup, Participates in project team meetings. • Assists the Project Management team in preparation for audits or inspections.• Works with the Project Managers to ensure all the required study documentation (agreements, site SOPs, etc) have been obtained from the site prior to site initiation.• Participates in the department review and update of SOPs when needed. • Assists with protocol development and review as needed.

• Site management responsibilities for 34 sites.• Assisted in the development of study related materials such as: patient brochures, patient recruitment materials, and presentations.• Trained and mentored CRAs.• Reviews site informed consent documents utilizing the ICF checklist to ensure all required elements are included.• Assisted with site nomination, qualification, and selection processes.• In consultation with the assigned filed clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site.• Coordinates activities with study specific committees, vendor services, and core labs.• Reviews and analyzes data and documents for accuracy and completeness. Creates and processes data queries.• Assists with follow-up and resolution of findings from monitoring visits and audits.

• Collaborates with the Clinical Project Manager in the design, administration and monitoring of clinical trials• Prepares and presents protocol and study-related presentations at investigator meetings to ensure that investigators are adequately informed of protocol requirements, standard operating procedures and monitoring procedures• Conducts site qualification visits which may include protocol review with investigators and site staff; assessment of investigator and site education and training; obtaining necessary information to evaluate the suitability of a site to conduct the clinical trial• Conducts site initiation activities including training the site staff on the protocol procedures, clinical trial material, lab processes, ICH/GCP and Investigator’s responsibilities, source documents, eCRF and the investigator binder• Conducts on-site and central monitoring to identify data entry errors and missing data in source records or CRFs; provides assurance that study documentation exists; assesses the familiarity of the site’s study staff with the protocol and required procedures; and assesses compliance with the protocol and investigational product accountability• Conducts critical analyses to identify data trends not easily detected by on-site monitoring • Performs standard checks of range, consistency, and completeness of data • Checks for unusual distribution of data within and between study sites (such as too little variance)• Analyzes site characteristics, performance metrics (e.g., high screen failure or withdrawal rates, high frequency of eligibility violations, delays in reporting data), and clinical data to identify trial sites with characteristics correlated with poor performance or noncompliance• Verifies critical source data remotely as described in the monitoring plan, in cases where such source data are accessible, or where CRF data are, per the protocol, source data

Irvine, Ca, Us

Durham, North Carolina, Us

• Perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs. • Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines. • Solid understanding of therapeutic indications and study hypothesis.• Provide site management responsibilities • Build relationships with investigators and site staff. • Performed on site visits in accordance with the monitoring plan.• Update all relevant tracking system on an ongoing basis.• Conduct on-site study-specific training when required or needed.

• Adhered with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner. • Knowledge of applicable SOPs, guidelines and study procedures; • Conducted study feasibility and site selection activities. • Assisted with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials; • Developed and implement innovative approaches for and participates in site recruitment, selection and initiation activities. • Attend investigator meeting activities and assist with organization. • Conducted site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits. • Ensured the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines. • Established and maintain good rapport with study sites. • Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines • Coordinated timely shipment of clinical supplies and study drug to sites. • Ensure proper storage, dispensation and accountability of clinical supplies and study drug. • Maintained adequate site tracking records • Communicated site study issues, concerns, and progress Project Manager, Clinical Team Lead, Regional Monitoring Manager and Clinical Operations Manager accordingly • Development and implementation of corrective actions when appropriate • Input and maintain study information concerning subject status of financial reimbursement to sites • Conducted on the job training and formal training to other CRAs. • Collaborate with Regional Monitoring Manager or Clinical Operations Manager /study teams to resolve site issues

• Manages all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity.• Scientifically monitors clinical studies, which includes the review of electronic case report forms (eCRF) and source documentation to ensure adherence to the protocol and consistency and scientific validity of the data.• Prepares Visit Reports and Status Reports for sponsors.• Coaches and mentors less experienced CRAs and assist in their development and training.• Provides full support including technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trails.

Princeton, New Jersey, Us

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct pre-study and initiation visits.• Manage small projects as directed by the Project Manager.• Responsible for all aspects of site management.• Perform eCRF (InForm) review, query generation and resolution.• Responsible for complete accurate monitoring reports.

Durham, North Carolina, Us

• Responsible for site management for two protocols at 12 sites and three protocols at 9 sites.• Responsible for communicating with Sponsor weekly on regional site status.• Designed and prepared protocol presentation for study team.• Prepared and conduct all site visits, but not limited to, qualification visits, initiation visits, monitoring visits, audit support visits, and termination visits.• Provided appropriate support for the preparation of submission/notification of local regulatory approval if required.• Reviewed source documentation and CRF for completeness for source verification.• Completed and submit monitoring and expense reports for review as required. • Tracked CRFs collected during monitoring visits to data management.• Completed and submit monitoring and expense reports for review as required by SOPs.

Wilmington, Nc, Us

Wilmington, Nc, Us

Wilmington, Nc, Us

Wilmington, Nc, Us