Clinical Trials Research Specialist - Family Medicine

University of Iowa - Iowa City, IA

Full-time - Mid Level

Iowa City, IA

Educational Services

About the position

The Clinical Trials Research Specialist in Family Medicine at the University of Iowa Health Care will play a crucial role in supporting research activities within the department. This position involves applying clinical skills to manage and evaluate research protocols, ensuring the effective recruitment and care of study participants while adhering to regulatory guidelines.

Responsibilities

• 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, providing ongoing assessment to determine if the plan is successful.
• Manage complex study recruitment materials for new and ongoing studies.
• 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.
• 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 and 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.
• 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, making recommendations for query resolution.
• Analyze data collection problems and implement change as needed.
• Manage and organize regulatory documentation and prepare and submit regulatory documents.
• Perform on-site audits of research and clinical data and monitor 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.
• Develop and administer study budgets and 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.
• 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.

Requirements

• 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.

Nice-to-haves

• 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.

Benefits

• Paid vacation
• Sick leave
• Health insurance options
• Dental insurance options
• Life insurance options
• Disability insurance options
• Generous employer contributions into retirement plans