EDWARDS

Clinical Research Coordinator 6300 (44142340)
Location: Vail, Colorado - United States
Posted: 11/22/2017

Clinical Research Coordinator 6300

Part-time (Year Around) Days POSITION PURPOSE: Two to three sentences describing the overall purpose of the position. Responsible for verifying that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete and verifiable from source documents. Additionally, the Clinical Research Coordinator makes sure that the conduct of the trial is in compliance with currently-approved protocol/amendments(s) and with applicable regulatory requirements. ESSENTIAL JOB FUNCTIONS: Maximum of ten functions in order of percentage of time spent on functions from longest to shortest; do not list anything that does not represent at least 10% of the job‚??s time. Please include supervisory responsibilities. Responsible for the management of clinical trials, including: analysis of potential patient recruitment, preparation of trial-related documentation, ensuring the safety and proper conduct of the trial, organizing IRB/Ethics committee submissions, and continued communication between all parties involved. Maintain files, including: IRB approvals, CV of investigators and study personnel, clinical investigator brochures, protocols, case report forms, consent documents, material shipping orders, letters of agreement, lab information, investigator and site correspondence, and schedules of payment. Maintain records of initial sponsor correspondence, records of IRB submissions, amendments, budgets, contracts, and/ or approved consents. Monitor updates and closures online. Manage patient recruitment strategies to increase patient accrual, including: investigator meetings, advertising, letters to appropriate physicians, being familiar with and distributing patient selection criteria, etc. Educate potential subjects on the details of the study. Follow study management policies and procedures regarding the registration of all study candidates. Prepare patient packets, including: consent with updated IRB, eligibility checklist, protocol treatment calendar, and lab certificates & reference ranges. Coordinate the subjects‚?? treatment scheduling process, as required by protocol. Complete Case Report forms for lab draws, proper storage of specimens, and preparation of shipping and receiving of specimens. Maintain, submit and track completed Case Report forms. Ensure that queries generated during cleaning are responded to in a timely manner. Collaborate with clinical staff and Principle Investigator to ensure tests and procedures that are required by clinical protocols are performed and documented, and charges from pharmacy are billed correctly. Initiate treatment and specimen collection. Maintain and document adequate follow-up with patients, physicians, and sponsors. Monitor and re-check nursing dosages to ensure the patient receives treatment per protocol and reports to SWOG organization. Recognize and follows protocol for legal reporting of adverse events to appropriate parties (e.g. Principle Investigator, SWOG organization). Attend investigator-coordinator meetings, initial orientations, study audits, and closeout visits. Perform other duties as assigned. Must be HIPAA compliant. This description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills and efforts or work conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job. MINIMUM QUALIFICATIONS: Requirements - Required and/or Preferred Experience: Previous experience with clinical trials required. Oncology-specific experience preferred. License(s): n/a Certification(s): Certified Clinical Research Professional certification (or working towards) preferred. Computer / Typing: Must possess, or be able to obtain within 90 days, the computers skills necessary to complete online learning requirements for job-specific competencies, access online forms and policies, complete online benefits enrollment, etc. Must be comfortable working with various software programs and be proficient with MS Office suite. Must have working knowledge of the English language, including reading, writing, and speaking English. Education:

Additional Requirments / Information

Job Capacity:Employee (part-time)
Minimum Education Level:See Job Description
Visa Sponsorship: No
Related Industries:Other
No Profile Available

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