The Clinical Trials Office is seeking applications for a Clinical Research Coordinator to support oncology-focused trials at IU Health West Hospital in Avon, Indiana. 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.
The CTO is seeking applications for our Clinical Research Coordinator position located at IU Health West Hospital in Avon, Indiana. This role coordinates sponsor-initiated and investigator-initiated oncology focused clinical trials for a disease-oriented team.
Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
Participates in study budget negotiations and reconciles study budget accounts.
Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
Stays up to date with knowledge of regulatory affairs and/or issues.
Note: This position may be eligible for a sign-on bonus.
EDUCATION / WORK EXPERIENCE
Bachelor's degree in science or a health-related field and 2 years of clinical research experience OR
Associate degree in science or a health-related field and 3 years of clinical research experience
Combinations of related education and experience may be considered
LICENSES AND CERTIFICATES
SOCRA/ARCP Clinical Research Certification upon date of hire
Demonstrated analytical skills
Ability to simultaneously handle multiple priorities
Possesses strong technical aptitude
Demonstrates a high commitment to quality
Excellent organizational skills
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.
IUSCCC Clinical Trials Office
IU Health West Hospital
Career Level: Career
Job Function: Research
Job Family: Clinical Research
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