Full job description
The University of Iowa Health Care department of Family Medicine is seeking a Clinical Trial & Data Management Research Associate to be an integral member of the research team. This position will provide support for Family Medicine by performing activities that are vitally important to the mission, as well as to grow and foster innovation through research support endeavors. The clinical trial research & data management associate will apply clinical skills to administer, deliver, and evaluate research protocols.
Duties to include:
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, possible 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 new studies and provide ongoing assessment to determine if the plan is successful.
Develop complex study recruitment materials for new and ongoing studies.
Assist in the design, development, execution administration, and maintenance of protocols and clinical studies.
Assist in study design, protocol development, 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.
Oversee database development and maintenance.
Review query reports. Resolve all monitoring visit issues.
Perform and monitor randomizations.
Develop complex study materials used in the conduction of study.
Serve as liaison to local healthcare practitioners, agencies, and sponsors as needed.
Participate in the development and testing of clinical research trial data systems for new studies.
Maintain communication between healthcare clinical information systems and research data systems.
Validate data and make recommendations for query resolution.
Revise and implement changes in data collection as needed.
Manage and organize regulatory documentation.
Prepare and submit regulatory documents.
Assist sponsor with on-site audits of research and clinical data.
Monitor and maintain compliance of regulatory guidelines and documents.
Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
May recommend corrective action for reportable events.
Assist with administering and monitoring study budgets.
Assist with tracking and reconciling grant budget-free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.
May provide functional and/or administrative supervision.
Educate and mentor staff at all stages of development and growth.
Percent of Time:
100%
Pay Grade:
4A
Benefits Highlights:
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.
The department intends to hire either a Clinical Trial & Data Management Research Associate (requisition ******** ) or a Clinical Trial & Data Management Research Specialist (requisition ******** ) based on the qualifications of the successful candidate. Please apply to the specific position for which you wish to be considered.
Required Qualifications
A bachelor's degree in a related field or an equivalent combination of education and experience is required.
1 year 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 the ability to perform meticulous work are desired.
Application Process:
In order to be considered, applicants must attach a resume/CV and cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.
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.
Up to 5 professional references will be requested at a later step in the recruitment process.
This position is not eligible for university sponsorship for employment authorization.
For questions or additional information please contact Austin Bullock at ********
#J-18808-Ljbffr
