PS Clinical Research Coord Sr

Job Summary
We welcome your application to join our team in conducting important and respected research studies across multiple states and partnering with multiple universities. This professional position coordinates complex clinical trial activities and plays a critical role in the management of these projects. Please see detailed responsibilities below. This position is eligible for university benefits including; medicaldentalwellness coverage an additional immediately vested 14.2 of salary employer contribution to retirement 401a) paid leave paid holidays tuition assistance for employees and family free UTA transport pass and others. See details at: Total Compensation Calculator Please apply at: Coordinate with a great deal of independence a large dynamic and interdisciplinary team that is across three institutions in the US. Manage the operations of a complex study with collection of specimens as well as patientreported outcome data. 2. Oversee assess and ensure participant safety and strict protocol implementation/ adherence; oversee compliance with GCP guidelines federal regulations institutional policies and procedures and internal SOPs. 3. Develop study budgets; monitor and billing; negotiate payment schedule and fees with sponsor. 4. Evaluate processes to identify obstacles to successful recruitment and retention of study participants. Recommend and implement innovative approaches to maximize enrollment and optimize subject retention. 5. Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks. 6. Implement procedures to prevent future events including staff education and retraining. 7. Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study. 8. Represent the research program at meetings national and international research consortia. 9. Prepare submit and maintain IRB DOD FDA NCI NIH NSF and/or other regulatory documents and research correspondence. 10. Assist in the selection and hiring process for study staff; supervise mentor and train new or junior research staff; provide direction and oversee preparation of study staff for monitoring visits; manage staff schedules ensuring shift/studies are covered; approve requests for time off/approve KRONOS . 11. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues. 12. Develop training and staff certification materials procedures and requirements. Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study. Oversee and train team members across the entire spectrum of research studies to include but not limited to: protocol requirements schedule of visits recruitment plan of research plan collecting adverse event information maintaining study subject documentation. Maintain records and other documentation of training. 13. Helps develop applicable data management queries and oversees data cleaning activities. 14. Determine subject population availability develop recruitment informed consents and screening materials; help develop survey and study data collection instruments. 15. Evaluate new protocols for feasibility. Thoroughly review study protocols and map process and data flow to predict areas of vulnerability. Identify recommend and implement solutions to address such vulnerabilities in specific trials and across the teams study portfolio. 16. Coordinate approval of new study agreements and contracts; assists in the development of case report forms. 17. Develops QA/QC processes and conduct quality control activities (field/study visits data queries). 18. Determine study visit and site/clinic workflows for studies/protocols. 19. Works with data managers to help design develop and test appropriate informatics tools to meet study data participant and sample tracking needs. 20. Helps to develop standard operating procedures. 21. Compiles information for grant applications. 22. Participates in abstract and manuscript preparation. 23. If not already certified: completion of CRC Certification within one year of hire required. 24. Other relevant duties as requested. The incumbent independently decides how to best accomplish the daily requirements of various study objectives prioritizes and delegates workload and establishes systems needed to achieve specific study goals. Works very closely as needed with study PIs to solve problems and determine workflows. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved. The incumbent functions independently under minimal supervision following FDA Good Clinical Practice IRB DOD NIH NCI NSF and/or other regulatory agency guidelines and seeking council from the Principal Investigators as necessary. The incumbent is expected to closely monitor use of experimental equipment and studyrelated devices (Fitbit). Because some subjects referred to participate on a research study have no other option for recovery the incumbent must be aware of the subjects condition well informed in the use of study material (devices equipment etc. and conscientious in his/her analysis of appropriate actions. The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed. This job description is not a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to the job.

Minimum Qualifications
Bachelors degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); plus 4 years professional research experience. Exceptional organizational skills attention to detail and demonstrated human relations and effective communication skills also required. Knowledge of Good Clinical Practices FDA HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred. Departments may require IRB CITI Course or IATA DGR training within a specified timeframe. This position is patientsensitive and must fulfill all associated requirements. We protect our patients coworkers and community by requiring all patientsensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.