CANCER CENTER (IN-CANC-IUINA)
The mission of the IU Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IUSCCC whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO provides a comprehensive range of services. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long-term follow-up.
- 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 oversees 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 keeps abreast with new research developments by attending continuing education meetings, lectures, training sessions and conferences.
- Bachelor's degree (preferably in science or a health-related field).
WORK EXPERIENCE Required
Preferred Combinations of related education and experience may be considered.
- 2 years of clinical research experience.
LICENSES AND CERTIFICATES Required
- ACRP or SOCRA Clinical Research Certification upon date of hire.
- Registered Nurse in the State of Indiana upon date of hire.
Working Conditions / Demands
- 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.
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.Work Location
IUSCCC Clinical Trials Office
Indianapolis, IndianaJob Classification
Career Level: Operational
Job Function: Research
Job Family: Clinical Research
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