For more than 90 years, the Department of Pediatrics at Indiana University School of Medicine has provided comprehensive medical training for medical students, residents and fellows in addition to lifelong learning opportunities for practicing physicians. The department consists of 19 specialty divisions based at Riley Hospital for Children at Indiana University Health, which is ranked as one of America's Best Children's Hospitals in 10 out of 10 specialties in US News and World Report .
The Division of Pediatric Endocrinology and Diabetology in the Department of Pediatrics at IU School of Medicine promotes the health of children with endocrine disorders, advances knowledge through research and other scholarly activities, and provides high-quality clinical services, child advocacy and medical education. The division is dedicated to biomedical education through instruction of medical, graduate and post-doctoral level students, as well as residents and fellows.
Oversees and directs the operations of the Type 1 Diabetes Research Group and serves as a liaison between faculty, staff, students, administration, and customers.
Involved with the developing and managing the research budgets, implementing continuous process improvement, and managing the performance and development for staff.
Responsible for tasks associated with assisting leadership to define and execute highly complex strategic plans for the research group in the division of Endocrinology and Diabetology.
Provides operational leadership and administrative direction for clinical research activities.
Analyzes, monitors, and evaluates performance of assigned staff; establishes work priorities, provides training, conducts performance reviews, and provides corrective action as needed.
Ensures adequate staffing and effective scheduling; participates and informs employment decisions for assigned staff.
Develops and coordinates departmental policies and procedures to ensure the efficient operation of both clinical trials and patient care; establishes standard operating procedures for the clinical research unit and ensures compliance with all internal and external requirements of regulatory agencies.
Evaluates protocol, study design, and assesses risk to subject population; monitors enrollment goals and modifies participant recruitment strategy, as necessary.
Oversees and ensures the implementation of the Principal Investigator's recommendation for adverse event interventions; ensures that serious adverse events are reported to sponsor and IRB and properly documented on source documents.
Designs and implements proper data management for data collection and tracking and/or oversee design of such databases.
Oversees the proper documentation at close-out as required by sponsor including return or disposal of unused supplies, reconciliation of test article accountability, study summary, evaluation of team efforts, and study "drop outs" and other required reports.
Assists and contributes to budget preparation and ensures adherence to grant sponsors, IRB and, university accounting and grant administration guidelines.
Acts as liaison between the research staff and the sponsors, IRB, federal, state and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues.
Expands knowledge base and keep abreast with new research developments by attending continuing education meetings, lectures, training sessions and conferences.
Bachelor's degree (preferably in science or health-related field).
2 years of clinical research experience.
Combinations of related education and experience may be considered.
LICENSES AND CERTIFICATES
ACRP or SOCRA Clinical Research Certification upon date of hire.
Registered Nurse in the State of Indiana upon date of hire.
Proficient communication skills.
Maintains a high degree of professionalism.
Demonstrated time management and priority setting skills.
Demonstrates a high commitment to quality.
Excellent organizational skills.
Excellent collaboration and team building skills.
Effectively coaches and delivers constructive feedback.
Instills commitment to organizational goals.
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: Operational
Job Function: Research
Job Family: Clinical Research
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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.
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