Indiana University School of Medicine is the largest medical school in the US and is annually ranked among the top medical schools in the US by US News & World Report. Please visit our website here for additional information about the Department of Medicine.
The Division of Cardiology at IUSM has multiple research laboratories conducting studies in various aspects of cardiovascular diseases, including but not limited to electrophysiology, genetics and pulmonary hypertension. The Krannert Institute of Cardiology Clinical Trial Office participates in multiple clinical studies related to clinical cardiology. There are ACGME approved cardiology training programs in cardiovascular diseases, cardiovascular electrophysiology, interventional cardiology and heart failure.
The Clinical Research Nurse will initiate, conduct, complete, and report clinical studies/trials in cardiology for the Krannert Institute of Cardiology. Manage patient interactions and follow-up including recruitment, consent, and study visits at Methodist Hospital, Eskenazi Health, and VAMC. Assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance. Schedule, prepare for and participate in monitor visits. Prepare and respond to Sponsor or FDA audits. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research. Expected to participate in on-call rotation for any studies that require 24/7 enrollment.
Other duties and responsibilities:
- Coordinate and administer new clinical research study activities and those studies from retired nursing staff.
- Actively recruit research participants to reach accrual goals.
- Complete local and Central IRB trial submissions for new studies.
- Complete Regulatory aspects of study start-up for new and ongoing studies.
- Data Entry of study data from ongoing and new studies (SHORE, as massive amounts of data are collected for each participant).
- Collect and report study data from ongoing and new Research participants including AE and SAE data as applicable.
- Provide guidance and support to junior level peers.
Bachelor's degree in nursing and one year of clinical nursing experience; OR associate's degree in nursing and three years of clinical nursing experience; OR LPN/diploma in nursing and four years of clinical nursing experience.
If not already certified, expected to obtain research coordinator certification through either ACRP or SOCRA as soon as two years of research experience is achieved. Possess significant understanding of regulatory affairs, as they impact the responsible conduct of research involving human subjects, including FDA, GCP, and institutional Standard Operating Procedures. Possess a highly competent, professional, yet friendly demeanor. Strong attention to detail, use spell and grammar check, and double check work before submitting. Good computer skills and proficiency with Microsoft Word and Excel. Detail oriented, well-organized, and possess the ability to manage multiple tasks and projects. Willing to not only maintain current knowledge regarding clinical research and regulatory affairs, but be interested in continuous self-improvement. Willingness to work as a positive team member in an active research group.
Salary Plan: PAE
Salary Grade: HE
Job Function: Health Services
Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment without regard to age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information .
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at firstname.lastname@example.org or by visiting IUPD.
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.