June 2022

To view the full job posting, please click the link: https://hrms.indiana.edu/psc/PH1PRD_PUB/EMPLOYEE/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_SCHJOB_FL&Action=U

Job ID299511
Location
Indianapolis, Indiana
Full-Time
Regular

Department
SCHOOL OF NURSING (IN-NURS-IUINA)

Department Information
Indiana University School of Nursing forms a core campus with locations on the Indianapolis (IUPUI), Bloomington, and Fort Wayne campuses and offers a full range of programs from undergraduate to doctoral. Robust clinical and academic partnerships throughout Indiana University and the state of Indiana provide support and new opportunities for interdisciplinary research and discovery.

Job Summary
The Clinical Research Specialist (CRS) will assist in the conduct and implementation of an NIH-funded study in the Indiana University School of Nursing that is led by Sheri Robb, PhD, MT-BC (Principal Investigator). The CRS will assign and coordinate activities of the project to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance. Additionally, the CRS will deliver study interventions for young children (ages 3 – 8 years) with cancer and their parents.

General Responsibilities

Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects; coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
Records study data, samples, and/or results in various databases; maintains databases for subjects and subject scheduling; performs data validation checks and pursues resolutions to erroneous data; produces various reports in response to requests from PI, sub-investigators, and/or other study stakeholders.
Monitors study team compliance with protocol and SOPs; submits all regulatory paperwork required; communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
May provide guidance and/or support to less experience clinical research staff.
Note: This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.