The University of Iowa Health Care Department of Family Medicine is seeking a Clinical Trial & Data Management Research Specialist. This position will be an integral member of the research team. This position will provide support for Family Medicine by performing activities which are vitally important to mission, as well as to grow and foster innovation through research support endeavors. The Clinical Trial & Data Management research specialist will apply clinical skills to administer, deliver, and evaluate research protocols.
Duties to include:
Research/Clinical Activities, Subject Recruitment and Enrollment
Perform clinical/health care research activities in the Department of Family Medicine.
Function as the specialist/technical expert in a specific skilled/specialized area.
Coordinate the care of research participants according to protocols requiring a high level of judgment and independent action.
Coordinate the screening of patients for study eligibility and consent for clinical trials.
Educate patient/participant on scope of study, potential risks and benefits, alternatives, and study requirements for patient/participant.
Develop and coordinate the delivery of information to principal investigators and verify participant eligibility. Review new protocols and assign to appropriate staff.
Screen, recruit, enroll and obtain informed consent for clinical research activities. Oversee the recruitment of participants and scheduling of trial-related procedures.
Develop new recruitment plans and methods for innovative studies, provide ongoing assessment to determine if plan is successful.
Manage complex study recruitment materials for new and ongoing studies.
Protocol Development/Management and Study Responsibilities
Develop, edit, coordinate, manage, and maintain protocols.
Collaborate with the Principal Investigator and the study team in the development, execution, administration, and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
Assess participants for problems related to protocol and communicate with the Principal Investigator to maintain proper protocol conduction by the study team.
Manage database development and oversee maintenance.
Review aggregate data from query resolutions. Resolve all monitoring visit issues.
Communicate with health care practitioners, agencies, and sponsors as needed.
Responsible for site management and daily activities associated with a clinical trial
Data Collection and Monitoring
Oversee the design; development and testing of clinical research trial data systems for innovative studies.
Maintain communication between healthcare clinical information systems and research data systems.
Collect and validate data. Make recommendations for query resolution.
Analyze data collection problems and implement change as needed.
Regulatory Guidelines and Documents
Manage and organize regulatory documentation.
Prepare and submit regulatory documents.
Perform on-site audits of research and clinical data.
Monitor and maintain compliance with regulatory guidelines and documents.
Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
Develop and conduct a corrective action plan for reportable events.
Financial Responsibility
Develop and administer study budgets.
Participate in the preparation of grant applications for extramural funding.
Aid with tracking and reconciling grant budget-free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.
Human Resources/Leadership
May hire, develop, and provide management of the day-to-day performance of staff; assure staff is compliant with UI policies and procedures.
Educate and mentor staff at all stages of development and growth.
Regular salaried position located in Coralville, Iowa
Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
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Required Qualifications:
A master's degree in a related field or an equivalent combination of education and experience is required.
3 years of related database management experience including entering, tracking, and maintaining data and troubleshooting, is required.
Desirable Qualifications:
Experience with REDCap, Epic and ACCESS is desirable.
Previous experience in data collection and entry is desirable.
Experience in processing research regulatory documents and budget preparation is desirable.
Excellent time management skills and ability to perform meticulous work is desired.
Application Process:
To be considered applicants must upload a resume and cover letter clearly stating how requirements are met. Up to 5 professional references will be requested at a later step in the recruitment process. Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.
This position is not eligible for university sponsorship for employment authorization.
For additional questions, please contact Sandy Plank at sandra-plank@uiowa.edu or 319-384-7949
