Starr Cook Email & Phone Number

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.

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.
• 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.
• 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.
• 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.

• 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.

• 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.

• 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.
• 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.
• 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.
• 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.
• Conducts critical analyses to identify data trends not easily detected by on-site monitoring

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.
• 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.

• 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.

• 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.

Wilmington, NC, US

Wilmington, NC, US

Wilmington, NC, US

Wilmington, NC, US