Responsible for coordinating, organizing and facilitating processes related to the development and completion of clinical research trials. This person will be a liaison between Investigators, Study Coordinators, Clinical Research Associates, and the Clinical Research Team.
Demonstrates understanding of applicable ICH Good Clinical Practice Guidelines, FDA regulations, and HIPAA regulations.
Prepare clinical research proposals for submission to funding bodies such as industry sponsors, private foundations, and government entities.
Coordinates the collaborative effort between IS department and research team in the production, testing, and implementation of the latest version of the Clinical Research System.
Responsible for writing, performing, and tracking testing scripts related to the electronic data capture system for trials.
Responsible for acting as the administrator or other assigned role in the Clinical Research System.
Coordinates the completion of site agreements and research contracts with the director, administration, legal department, and site representatives.
Maintain Internet and Intranet websites dedicated to research personnel and trials through MedSeek SiteMaker software program.
Assist with planning of investigator meetings. May require travel to assist with investigator meetings on site.
Review research protocols for clarity, required elements, human subject’s protection issues, and research compliance.
Proof protocols, manuscripts, and other related research documents for proper formatting, grammar, spelling, etc. as well as track versions for sponsors.
Coordinate the development of forms and surveys; assist in writing procedural manuals for data collection and coding for research trials.
Maintain budget spreadsheet for each clinical trial and coordinates payments with Director and the accounting department.
Create and maintain master spreadsheets that include but are not limited to, participant lists, IRB approval and consent approvals, and essential documents for each site participating in a clinical trial.
Responsible for collection and maintenance of essential documents (FDA and trial specific documents) required for clinical trials. Responsible for obtaining completed, updated or current versions of all documents.
Responsible for writing, performing, and tracking (Remedy System) testing scripts related to the electronic data capture system for one or more trials.
Interact with other departments within the Corporate Office to facilitate the research projects that include but are not limited too, legal department, user services department, accounting department, travel, and marketing.
Conduct audits on regulatory, IRB, site study files, and other study related documents for completeness.
Expedite incoming questions/problems by site Investigators and research team and coordinate the solution with appropriate resources.
Write and/or revise Standard Operating Procedures (SOPs) as directed. Maintain master copy of SOPs.
Follow company and departmental SOPs.
Screens and prioritizes all requests and provides prompt, courteous, professional, and accurate information in all communications in dealing with physicians and other departments.
Responsible for following all facility, organization, and department precautions and procedures in the performance of all job duties to ensure a safe work environment for self and others.
Other duties as assigned.
Associate's degree (A. A.) or equivalent from two-year College or technical school; or six months to one year related experience and/or training; or equivalent combination of education and experience.
This position requires excellent organizational and management skills, resource planning, and the ability to work both autonomously and in teams.
Understanding of FDA, HIPPAA and good clinical practice guidelines for research.
Ability to coordinate several large multi center trials is highly desirable.
Previous experience working on industry sponsored trials.
Experience working with Clinical Trial Management systems.
Intermediate knowledge of Excel and other Microsoft Office programs.
Experience with preparation of research proposals to funding entities.
Mednax - 12 months ago
MEDNAX is a multi-specialty medical group with a national focus. It is the holding company of Pediatrix Medical Group, American...