100,000's of Government Jobs

Search Government Jobs

Job Field: Government Jobs
Location: SALT LAKE CITY, UT
Job Type: Full Time

JOB SUMMARY:

---

Under general direction, monitors the initiation and performance of clinical trials at external research sites to assure compliance with all study procedures and regulatory requirements. Serves as the primary liaison with the research site, tracks the progress of the study and resolves problems with the study execution. Conducts site qualification, site initiation, interim monitoring, and study termination visits. Assists with the development of study protocols, and identifies potential research sites. Essential job functions: * Carries out responsibilities in accordance with the organizationamp;apos;s policies, procedures, and state, federal and local laws. * Assists with the development of study protocols and the identification of potential investigators and clinical research sites. Conduct qualification visits for selected sites. * Contributes to Investigator Meetings in the form of coordinator training and formal presentations. * Assures that research site personnel are conducting the study according to the protocol and that sites are in compliance with all applicable regulatory requirements and GCP guidelines. * Serves as the primary liaison with research sites; monitors the day-to-day conduct of the study and resolves problems associated with the study; provides administrative and logistical support as required. * Creates site-specific study files, and collects and maintains all required documentation and correspondence. * Tracks and reports on the progress of the study, including significant deviations from timelines or enrollment targets. Identifies reasons for poor or under performance. * Performs monitoring visits including site initiation, interim monitoring, and study termination visits. Prepares and submits accurate and timely monitoring reports. * Reviews screening data to confirm eligibility for inclusion of study participants; reviews and verifies data for screen failures. * Verifies the accuracy and completeness of CRF data against source documents; assures timely and complete shipping of CRFs for data entry. * Interacts with the clinical study sites to resolve data queries, errors and omissions, and obtain additional information on potential serious adverse events. * Contributes to the preparation of clinical study report appendices. * Provides guidance and coaching to more junior CRAS. * Performs related duties as assigned.Four (4) to six (6) years experience as a CRA in the pharmaceutical industry or for a Clinical Research Organization. Supporting Clinical Trial Research, or other clinical research service provider, or an equivalent combination of education and experience. Knowledge of: * Clinical trial research methods and procedures. * Therapeutics, medical terminology and therapeutic agents. * FDA regulations pertaining to clinical studies. * Good Clinical Practices guidelines. * Business and scientific software applications. * Business English usage, spelling, grammar and punctuation.Bachelors degree in life sciences or health-related field.

KEY REQUIREMENTS:

---

High School Diploma