We are seeking an individual to assist with ongoing research and development activities on the team of Dr. Korey Kennelty in the College of Pharmacy. A highly motivated Research Associate is needed for funded research projects studying team-based care, particularly in the field of medication management in adults living with multiple chronic conditions. This position will have a focus on subject recruitment, conducting interviews, and submitting IRB applications.
This is a specified-term appointment at a 100% effort for two years. After two years, the specified-term appointment may be eligible for renewal dependent on funding.
Key Areas of Responsibility
Protocol Development/ Management and Study Responsibilities * Assist in the design, development, administration and maintenance of clinical study protocols. * Assist in writing the formal study protocol, draft updates when needed, and distribute the protocol to participating sites, the IRB, and grants program officer. * Train site research team members on the study protocol. * Draft and update all policies and procedures and operations manuals for study procedures and data abstraction. * Assist in the randomization of participating study sites and notify sites of their assigned study arm. * Serve as liaison to members of site research teams and to funding sponsor. * Create meeting agendas and convene and oversee research management meetings.
Research/ Clinical Activities; Subject Recruitment and Enrollment * Assist with and oversee all aspects of study participant recruitment. * Review query reports to ensure that all subjects meet the specified eligibility criteria.
Data Collection and Monitoring * Oversee development of case report forms that capture all variables required for data analyses. * Coordinate initial site visits. * Interview study subjects, collect their medication and other clinical data over the phone, and submit audio for transcription. * Review query reports to ensure that: - Data collection timetables are met - All case report forms are complete and consistent * Assist with the development of data reports and preparation of abstracts, posters, presentations and manuscripts for publication.
Regulatory Guidelines and Documents * Lead all aspects of IRB application processes, using the SMART IRB platform with the UI IRB as the IRB of record: - Draft an IRB modification application to the University of Iowa Human Subjects Office that specifies all details of the study and secure IRB approval. - Negotiate with the UI IRB your responsibilities and those of the study PI under the SMART IRB agreement. - Provide the UI IRB with contact information for site IRBs and study team members. - Provide study team leaders with the IRB-approved versions of all study documents. - Using the SMART IRB platform, work with the UI IRB to negotiate agreements with participating study sites to have the UI IRB serve as the IRB of record for the study. - Submit modifications to the UI IRB as site SMART IRB agreements are finalized. - Submit continuing review applications annually. - Submit serious adverse event and unanticipated problem reports to the IRB. * Coordinate with College of Pharmacy Research Office for submitting funding progress reports.
Human Resources/ Leadership * Supervise students working on grant projects. * Orient students to data entry. * Track student progress with/completion of assigned projects.
Financial Responsibility * Track supply needs and work with the Program Manager to purchase and replenish materials.
For a complete job description including all Key Areas of Responsibility and Universal and Technical Competencies, please send an email to email@example.com.
Bachelor's degree or equivalent combination of education and experience is required.
Experience Required Demonstrates an extensive level of proficiency in the following competencies or qualifications: * Effective communication (written and verbal), ability to effectively and accurately exchange, transmit, receive, and interpret ideas, information and needs with team members through appropriate communication methods. Demonstrates a working level of proficiency in the following competencies or qualifications: * Knowledge and ability to use Microsoft Office (i.e., Word, Excel) * Knowledge and ability to use an electronic medical record systems or pharmacy medication records clinically, administratively, or for research purposes * Submission of IRB applications Ability to occasionally travel to study sites for monitoring and data collection.
A valid driver's license, plus the ability to meet and maintain The University of Iowa's Fleet Safety Standards
Highly Desirable: Previous clinical experience (e.g., pharmacy technician, nursing assistant) including having familiarity with prescription and over-the-counter medication names. At least one year working on a clinical trial. Desirable: * Fluent in written and spoken Spanish
Demonstrates a working level of proficiency in the following competencies or qualifications: * Submitting annual reports to foundation and federal funding agencies
In order to be considered for an interview, applicants must upload a submission-specific resume and cover letter and mark them as a "Relevant File" to the submission.
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 subject to a criminal background and credential check. 5 professional references will be requested at a later step in the recruitment process.
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.
Internal Number: 21002499_1620942978
About University of Iowa
With over 31,000 students, the University of Iowa is one of the nation's top public research universities, a member of the Big Ten conference and the Association of American Universities. The University of Iowa is composed of eleven colleges and is known around the world for its balanced commitment to the arts, sciences, and humanities. It is home to one of the nation's largest academic medical centers and the pioneering Iowa Writers' Workshop. The University of Iowa promotes work/life integration and is located in the casual yet cosmopolitan environment of Iowa City, widely recognized as one of the country's most livable communities.
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