The clinical research nurse will coordinate and implement pediatric diabetes clinical research under the direction of the clinical research nurse manager and principal investigator in accordance with good clinical practice and institutional standard operating procedure. Participate in initiation, recruiting, documentation, monitoring, completing and reporting of routine to moderately complex clinical studies.
Primary responsibilities include:
Recruit participants according to IRB approved methodologies. Using acceptable procedures, review records and identify and screen potential participants to ensure they meet the study criteria. Monitor enrollment goals and modify recruitment strategies as necessary.
Ensure appropriate informed consent processes are followed: including discussions of treatment and intervention alternatives, voluntary nature of the study, ongoing opportunity for questions and discussions, understanding of participant, assent when appropriate, and proper documentation of process.
Coordination of visits. Schedule participant visits with support services, and perform interviews and clinical assessment to collect data required by the protocol. Complete source documents, case report forms, and other paperwork for study visits. Evaluate patient status for safety and ensure optimum health care.
Attend and participate in investigator meetings and calls with the sponsors. Review and assess progress and conduct of study design and implementation.
Maintain study files, provide copies of forms to study sponsor, IRB, general clinical research center, FDA etc., including reporting of SAEs, AEs per regulatory and institutional guidelines. Act as a liaison between research staff, study sponsor, IRB, federal state and University officials and other regulatory agencies.
Order and receive drug/device supplies. Dispense drug (calculate dosage as needed), supplies, and devices according to sponsor directions and institutional procedures. Provide clear instructions to the participants and/or their families.
Ensure proper collection, documentation, processing and shipment of specimens.
Oversee proper documentation of close-out as required by grant sponsors including return of unused supplies, reconciliation of test/drug accountability forms, study summary, evaluation of team effort, and subject enrollment. Prepare and respond to sponsor or FDA audits.
Expand knowledge base and remain abreast of new research developments by attending continuing education meetings, lectures, training and conferences.
Other responsibilities include:
Initiate, conduct, monitor, and coordinate clinical studies or trials in accordance with protocols, regulatory and standard operating procedures (SOP), and Good Clinical Practice (GCP) compliance. Assist PI and participate in protocol development, evaluation, and review of risk assessment; evaluate study design and risk to subject population; determine staff, facility, and equipment availability; assess study population/availability.
Compose and submit continuing review, amendments, and close out information; schedule and prepare for monitor visits; prepare and respond to Sponsor and/or FDA audits.
Design recruitment strategies for each assigned study; recruit subjects according to IRB/protocol approved methodologies; consent subjects, including discussion of treatment and intervention alternatives; monitor enrollment goals and modify recruitment strategy as needed.
Liaison with healthcare professionals/providers to determine best recruitment practices for study; manage subject recruitment including marketing, screening procedures, and enrollment.
Ensure proper collection, processing, shipment of specimens, and documentation; communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings; record and document protocol deviations; communicate with PI and sub-investigators about changes in the trial.
Participate in preparation and negotiation of study budget and reconciles study budget accounts.
Review, critically evaluate, and comment upon study contracts/agreements.
Prepare and submit Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary).
Schedule study-related meetings and training sessions and provide instruction to study team for specific study assignments; educate staff regarding scientific aspects of study and train ancillary staff regarding clinical studies or trials; monitor study team compliance with required study procedures and GCP standards.
Manage research study inventory and supplies (such as medications, equipment, devices) and maintain required compliance documentation.
Stay up-to-date and maintain current knowledge of regulatory affairs and/or issues; maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
Must meet one of the following qualifications:
Bachelor's degree in nursing plus one year of clinical nursing experience; OR
Associate's degree in nursing plus three years of clinical nursing experience; OR
High school diploma or GED with LPN plus four years of clinical nursing experience.
Combinations of related education and experience may be considered.
Licensed Practical Nurse (LPN) upon date of hire.
Ability to simultaneously handle multiple priorities. Experience in a regulated environment. Demonstrates a high commitment to quality. Ability to analyze and interpret financial data. Effective interpersonal skills. Ability to build strong customer relationships.
ACRP or SOCRA Clinical Research Certification upon date of hire.
Working Conditions / Demands
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
Career Level Competencies:
Optimizes Work Processes: Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.
Action Oriented: Taking on new opportunities and touch challenges with sense of urgency, high energy, and enthusiasm.
Career Level Dimensions:
Requires intermediate knowledge and understanding of principles and skills necessary to perform in profession or particular area of specialization.
Requires core understanding of organizational technologies and practices.
Problem Solving and Complexity
Requires the ability to apply sound judgment and apply experienced analysis techniques within area of specialization to make decisions.
Decision-making authority is limited to functional area.
Sets priorities and/or sequence of tasks to achieve objectives with some oversight.
Autonomy and Decision-Making
Requires the ability to identify and resolve moderately complex problems/issues/ assignment.
Requires core problem-solving skills and techniques.
Scope and Impact
Duties and responsibilities have scope and impact that extend beyond the functional area.
Leadership and Influence
Influence is limited to functional area and unit/team.
Often provides guidance and support to junior-level peers.
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 .
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About Indiana University Purdue University Indianpolis - IUPUI
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.