Job Description
The University of Iowa Carver College of Medicine department of Dermatology is seeking a Clinical Trials Research Assistant 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.
- 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.
The Roy J. and Lucille A. Carver College of Medicine is a highly ranked medical school where students learn to become accomplished clinicians and top-flight researchers and educators. Students come to Iowa to study medicine in a program that uses case-based learning as the basis of their education. With its emphasis on problem-solving skills, early exposure to patients, and enhanced community-based experiences, UI medical students typically earn impressive scores on Step 1 of the U.S. Medical Licensing Examination and successfully “match” with top-quality residency programs around the country.
Percent of Time: 100%
Salary: 3A
Benefits Highlights - Regular salaried position located in Iowa City, Iowa
- Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
- For more information about Why Iowa?, click here
- The University of Iowa offers a generous benefits package, including 24 days paid vacation per year to start and paid sick leave. Complete information regarding the full benefits package may be viewed at:
Required Qualifications - A Bachelor of Science degree or an equivalent combination of education and experience.
- 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)
Desirable 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 Process: In order to be considered, applicants must upload a resume 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.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.
This position is not eligible for University sponsorship for employment authorization.
With additional question, please reach out to Adam Santi at adam-santi@uiowa.edu
Additional Information
- Classification Title: Clin Trials Rsrch Asst/Data Mg
- Appointment Type: Professional and Scientific
- Schedule: Full-time
Compensation Contact Information
- Organization: Healthcare
- Contact Name: Adam Santi
- Contact Email: adam-santi@uiowa.edu
Job Tags
Full time,