MD Anderson Cancer Center Coordinator, Clinical Research Program - Pediatrics Research Program in Houston, Texas
Coordinator, Clinical Research Program opportunity in Pediatrics – Patient Care
Ideal candidate must have a Bachelor's degree and three years' experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. Prefer candidates that have their SoCRA certification.
The incumbent coordinates and manages the submission process of new and amended federal and industry funded research studies in the Department of Pediatrics Patient Care.
Salary Range: $50,800 - $63,500 - $76,200
JOB SPECIFIC COMPETENCIES
Administrative Management of Clinical Trials: Manage administrative/regulatory aspects of research trials for federal and pharmaceutical funded protocols, through all components of a study. Works with PI's, sponsors, Clinical Research Organizations (CRO) and team members to prepare and submit regulatory documents, respond to protocol reviewer's comments. Coordinate with sponsor representative to assure consistency and maintain standard record documentation. Coordinate activities associated with site start-up and overall regulatory trial management.
Coordination with Sponsors: Act as a Pediatrics' primary liaison with legal services and sponsors for industry sponsored projects. Coordinate activities associated with site start up and overall regulatory trial management. Assure the PI and research team are current on regulatory requirements
System Development: Develop and maintain a processing and tracking system for all protocol related paperwork. Collect and develop criteria information for protocol submission. Creates and maintains organizational files which include all pertinent correspondence and information regarding pre-award activities for pediatric clinical trials. Maintains an up-to-date status report and creates summary reports as requested for supervisor, PI, and/or management staff.
Audit and Quality Monitoring: Prepares and coordinates audit/monitor visits for protocol compliance and data quality review. Generate reports as requested. Assure accurate documentation.
Other duties as assigned
Education: Bachelor's Degree
Preferred Education: Master's Level Degree
Preferred Certification: SOCRA
Experience: Three years' experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis.
Preferred Experience: None
Onsite Presence: Is Not Required
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Employee Status: Regular
Minimum Salary: US Dollar (USD) 50,800
Midpoint Salary: US Dollar (USD) 63,500
Maximum Salary : US Dollar (USD) 76,200