W - Welcoming - We have an environment where everyone has a voice that is heard; that promotes the dignity of our patients, trainees, and employees; and allows all to thrive in their health, work, research, and education.
Clin Trials Rsrch Asst/Data Mg
The Department of Dermatology is seeking an individual to support, conduct and manage clinical trials to deliver and evaluate research protocols. Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines and documents and financial responsibility.
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Position Responsibilities |
- Prepare regulatory documents for sponsor approval.
- Prepare IRB documents for protocol approval.
- Research, change, and submit protocol amendments for IRB approval.
- Submit protocol data, yearly renewals, and study modifications to the IRB in a timely fashion.
- Monitor protocol status as it is process through the IRB.
- Submit applications to the CRU for clinical studies that will utilize their services.
- Communicate to sponsors.
- Manage and maintain protocols.
- Monitor visit reports for all studies.
- Responsible for conducting training of new protocols and changes to existing protocols.
- Responsible for site management and daily activities associated with a clinical trial; respond to clinical site monitoring questions regarding data collection and data entry issues.
- Participate in clinical research visits, which may include Epic documentation, checking vitals and drawing blood.
- Consult with researchers to assist in development of data management plans; design forms to facilitate the collection and tracking of study participant data, study drugs, biological specimens and study procedures.
- Assist in the design, development, execution, administration and maintenance of protocols and clinical studies.
- Assist with clinical and data coordination for research activities and set up supplies for study visits.
- May assist with subject recruitment by mining databases and EPIC.
- May assist with subject recruitment by recruiting subjects from the providers clinics in the Dermatology Clinic.
- May complete telephone screening of potential subjects to determine initial eligibility for enrollment.
- Manage and organize regulatory documentation from sites and regulatory authorities.
- Monitor compliance of regulatory guidelines and proper maintenance of documents.
- Complete regulatory submission and close out process.
E - Excellence - We achieve and deliver our personal and collective best in the pursuit of quality and accessible health care, education, and research.
C - Collaboration - We collaborate with health care systems, providers, and communities across Iowa and the region as well as within our UI community. We believe teamwork—guided by compassion—is the best way to work.
A - Accountability - We behave ethically, act with fairness and integrity, take responsibility for our own actions, and respond when errors in behavior or judgment occur.
R - Respect - We create an environment where every individual feels safe, valued, and respected, supporting the well-being and success of all members of our community.
E - Empowerment - We commit to fair access to research, health care, and education for our community and opportunities for personal and professional growth for our staff and learners.
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Education Requirements |
A Bachelor’s of Science degree or an equivalent combination of education and experience
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Experience Requirements |
- 6 months to 1 year of related experience
- Excellent written and verbal communication skills
- Experience with preparation of IRB or regulatory submissions
- Proficiency in computer software applications (MS Word, Excel, Outlook and PowerPoint)
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Desired Qualifications |
- Experience with RedCap database is desirable
- Experience with Epic is desirable
- Experience with following specific protocol techniques and management is desirable
- Basic experience and participation with clinical trials is desirable
- Certification that allows for blood draw (Phlebotomy Technician, Certified Medical Assistant, LPN, RN) is desirable
APPLICATION DETAILS
In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:
- Resume
- Cover Letter
Job openings are posted for a minimum of seven 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 not eligible for University sponsorship for employment authorization.
For additional questions, please contact Lisa Pfannebecker, HR Generalist, at lisa-pfannebecker@uiowa.edu or 319-384-9239.
Equal opportunity employer
The University of Iowa is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, or associational preferences.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
