Location
Iowa City, IA | United States
Job description
The University of Iowa Hospitals and Clinics Department of Urology is seeking a Clinical Trial and Data Management Research Specialist to develop, manage, coordinate and maintain clinical research activities. Key areas of responsibility include protocol development/management and study duties; subject recruitment and enrollment; data collection and monitoring; regulatory guidelines and documents; human resources/leadership; financial responsibilities.
Basic Duties and Responsibilities:
Protocol Development/ Management and Study Responsibilities:
- Develop, edit, coordinate, manage, and maintain protocols.
- Develop study materials.
- Establish study-related metrics for efficiency and success.
- Prepare, evaluate and analyze specialized reports.
- Resolve queries.
- Review aggregate data from query resolutions and monitor visit reports for all assigned studies.
- Communicate with multi-center health care practitioners, agencies and sponsors.
- Responsible for site management and daily activities associated with a clinical trials/research projects; respond to clinical site questions regarding data collection and data entry issues; provide training and guidance; organize and facilitate meetings, etc.
Research/ Clinical Activities; Subject Recruitment and Enrollment:
- Perform clinical and data coordination functions.
- Coordinate the care of research participants according to protocols requiring a high level of judgment and independent action.
- Manage the recruitment of subjects. Screen, recruit, enroll and obtain informed consent for clinical trials/research projects.
- Educate study participants on scope of study, potential risks and benefits, possible alternatives and study requirements.
- Review new protocols and assign protocols to staff.
- Prepare and participate in monitoring visits.
- Assure compliance with study protocol.
- Obtain clinical trial specimens.
- Organize and schedule clinic/study visits, follow study participants.
Data Collection and Monitoring:
- Collect and enter clinical research data required by the sponsors in a timely manner.
- Evaluate and analyze data collection procedures.
- Update and maintain the requirement and specifications for the electronic data capture systems.
- Perform quality assurance checks to assure data collection validity.
Regulatory Guidelines and Documents:
- Manage and organize regulatory documentation from sites and regulatory authorities.
- Prepare, submit and manage regulatory submissions, including IRBs.
- Perform on-site audits of research and clinical data.
- Communicate with IRB staff, investigators, and regulatory authorities.
- Monitor compliance of regulatory guidelines and proper maintenance of documents.
- Manage safety of subjects.
- Assume responsibility for reportable events reporting, and any corrective actions taken.
Human Resources/ Leadership:
- Provide training and guidance to new staff and students; ; assure staff is compliant with UI policies and procedures.
- Provide functional and/or administrative supervision.
- Attend protocol meetings and other UIHC and Study Sponsor meetings; participate on committees as appropriate.
Financial Responsibility:
- May provide budget information and work in coordination with Urology Research Administration to assure completion of study related fiscal tasks.
Required Qualifications
- Master’s degree or an equivalent combination of education and experience.
- 3 – 5 years of experience conducting clinical research with human subjects.
- Knowledge and experience of regulatory guidelines and procedures, including managing and processing Institutional Review Board (IRB) regulatory requirements.
- Excellent written, verbal and interpersonal communication skills.
- Ability to manage complex information with attention to detail and a high level of accuracy.
- Proficiency in computer software applications including spreadsheet and database applications.
- Demonstrated organizational skills.
Desirable Qualifications
- Knowledge of University of Iowa/University of Iowa Hospitals and Clinics policies, procedures and regulations.
- Experience with following specific protocol techniques and management.
- Experience working in an academic research institution.
- Experience with Epic or other electronic medical records (EMR) systems.
- Knowledge of urology research.
Application Process:
In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:
Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original 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 eligible for a combination of on-campus (UIHC) and remote work. Remote work must be performed at an offsite location within the state of Iowa. Per policy, work arrangements will be reviewed annually, and must comply with the remote work program and related policies and employee travel policy when working at a remote location. Work arrangement options will be discussed during the hiring process.
This position is not eligible for University sponsorship for employment authorization.
For additional questions, please contact Sandy Moenk at [email protected] or 319-356-0748.
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