Curtis Harrison Email & Phone Number

Durham, North Carolina, Us

Durham, North Carolina, Us

Los Gatos, California, Us

Morrisville, Nc, Us

Morrisville, Nc, Us

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 of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assigned• Responsible for aspects of registry management as prescribed in the project plans• General On-Site Monitoring Responsibilities:o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyo Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementso Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewo Monitor data for missing or implausible datao Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policyo Prepare accurate and timely trip reports• Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management• Provide coverage for clinical contact telephone lines, as required• Update, track and maintain study-specific trial management tools/systems• Generate and track drug shipments and supplies, as needed• Track and follow-up on serious adverse events as assigned• Implement study-specific communication plan as assigned• Trip report review

Princeton, New Jersey, Us

• Acted as contact for project team and study sites• Performed CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management• Assisted with generation and reconciliation of queries to investigative sites/clients to resolve problem data• Assisted with the management of study supplies and organized shipments• Created, updated, tracked, and maintained study-specific trial management files, tools, and systems• Assisted the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings)• Coordinated meetings with clients, investigators, and project team, including taking minutes• Ensured compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work• Provided input in writing Monitoring Conventions as assigned• Assisted in submissions and notifications to Ethics Committees and Regulatory Authorities• General On-Site Monitoring Responsibilities:o Assisted Senior Clinical Research Associates, Clinical Research Associates-2 and Clinical Research Associates-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)o Initiated, monitored and closed out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Senior Clinical Research Associates, Project Managers or Project Directors• Performed other duties as assigned by management

- Generating sales quotations for customers, using dedicated sales database systems- Ensure the integrity of client information maintained in the database systems- Generating reports for internal use by mining information from various computer packages- Updating and managing Excel spreadsheets- Dealing with external and internal queries in a professional, client orientated manner- Checking the data integrity of purchase orders and invoices- Working with team members and reporting lines to further enhance existing processes to ensure maximum automation and efficiency

Bachelor'S Degree, Communications And Journalism

Master Of Business Administration (M.B.A.), International Business