<p>Position Summary:</p> <p>Prepares, submits and maintains clinical trials regulatory data and documents. Initiates and maintains all Regulatory documents necessary for submission to Institutional Review Boards, study sponsors, and various agencies in order to obtain initial and continued approval of all clinical trials. Performs data entry to CTMS and maintains accuracy of CTMS for all assigned clinical trials.</p> <p>This position functions as an integral part of a project team whose objective is to assist study sponsors, physicians, and patients enroll and complete clinical research trials. This position is responsible for all regulatory document coordination, filing, monitoring and reporting to the project team regarding regulatory information.</p> <p>Efficiency and Effectiveness</p> <p>Maintains IRB status, consent form versions, protocols and safety information</p> <p>a. All documents maintained with 100% accuracy.</p> <p>b. All documents filed within three (3) business days of receipt.</p> <p>c. Current and archived versions maintained in correct file with 100% accuracy.</p> <p>Prepares regulatory documentation packets and creates all FDA 1572 Forms. Ensures all necessary forms are submitted to Sponsor company to activate site for patient enrollment.</p> <p>a. All regulatory packets prepared within thirty (30) days of sponsor request.</p> <p>b. All packages prepared with 100% accuracy.</p> <p>Distributes IRB documentation and post IRB meeting information to study sponsors, research and clinical staff, as appropriate and necessary.</p> <p>a. Documents and information distributed within two (2) days of receipt.</p> <p>Ensures all regulatory files are prepared for storage and retained in accordance with FDA, IRB, sponsor, institution and any other appropriate regulatory guidelines.</p> <p>a. Retention policies followed with 100% compliance.</p> <p>Maintains log of all studies with file destruction dates per contract. Pulls files from storage and sends to be destroyed according to contract</p> <p>a. Maintains log with 100% accuracy.</p> <p>b. Sends files for destruction per sponsor contract requirements on monthly basis.</p> <p>Serves as primary team member to answer department main phone line and monitor department main line voice mail.</p> <p>a. Answer main phone line within five rings. Phone should not go to voice mail during business hours.</p> <p>Quality and Safety</p> <p>Reports, monitors, distributes and maintains files for all safety information including, but not limited to, Investigational Drug Brochures, IND safety reports, Serious Adverse Event reports.</p> <p>a. All documents filed within three (3) business days of receipt.</p> <p>b. Documents filed in appropriate binder/file with 100% accuracy.</p> <p>Prepares, maintains, updates and audits study specific regulatory files, IRB files and location profile files per FDA guidelines and resolves queries as necessary.</p> <p>a. Internal audits (cross-position) performed quarterly with 90% accuracy.</p> <p>b. Queries resolved within five (5) business day.</p> <p>c. Monitor letters and reports submitted to Director-Regulatory within two (2) days of receipt.</p> <p>d. Regulatory deviations, issues or problems (within Regulatory Coordinator control) identified in monitor letters and reports resolved or action plan determined within ten (10) business days.</p> <p>Position Qualification:</p> <p>1-3 years</p> <ul> <li>Proficient in Microsoft Word, Excel, e-mail and other commonly used computer software. </li><li>General human anatomy knowledge and familiarity with medical terminology preferred. </li><li>Knowledge of clinical trials regulatory guidelines and requirements preferred. </li><li>1-3 years experience working with pharmaceutical/biotech/medical devices sponsors preferred. </li><li>Knowledge of regulatory agencies/guidelines (FDA) preferred. </li></ul> <p>Education</p> <p>Associates Healthcare Preferred</p> <p>Years of Experience can be related experience and/or training; or equivalent combination of education and experience.</p>