Clinical Research Nurse

About the role

The mission of the Indiana University (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.

Responsibilities

• Assists principal investigator (PI) and participates in protocol development, evaluation, and review of risk assessment;
• Evaluates study design and risk to subject population;
• Determines staff, facility, and equipment availability;
• Designs recruitment strategies for each assigned study;
• Recruits subjects according to the institutional review board (IRB)/protocol approved methodologies;
• Consents subjects including discussion of treatment and intervention alternatives;
• Maintains subject recruitment including marketing, screening procedures, and enrollment;
• Ensures proper collection, processing, shipment of specimens, and documentation;
• Communicates with laboratory, PI, and sponsor regarding laboratory findings;
• Records and documents protocol deviations;
• Communicates with PI and sub-investigators about changes in the trial;
• Participates in preparation and negotiation of study budget and reconciles study budget accounts;
• Reviews, critically evaluates, and comments upon study contracts/agreements;
• Prepares and submits IRB documents (i.e., Informed Consent, advertisement, protocol and protocol summary);
• Schedules study-related meetings and training sessions and provides instruction to study team for specific study assignments;
• Edits and trains ancillary staff regarding clinical studies or trials;
• Maintains study team compliance with required study procedures and Good Clinical Practice (GCP) standards;
• Manages research study inventory and supplies (such as medications, equipment, devices) and maintains required compliance documentation;
• Composes and submits continuing review/amendments/close out information;
• Schedules and prepares for monitor visits;
• Prepares and responds to Sponsor and/or FDA audits;
• Stays up-to-date and maintains current knowledge of regulatory affairs and/or issues;
• Maintains a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.

Requirements

• Education beyond the minimum required may be substituted for work experience.
• Work experience beyond the minimum required may be substituted for education.
• Required Bachelor's degree in nursing plus at least 1 year of clinical nursing experience; OR Associate's degree in nursing plus at least 3 years clinical nursing experience; OR High school diploma or equivalent (such as HSED or GED) plus at least 4 years of clinical nursing experience.
• Required Licensed Practical Nurse (LPN) upon date of hire.
• PREFERRED Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire.

Skills

• 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.
• 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.
• The role requires the ability to effectively communicate.

Benefits

IUSCCC Clinical Trials Office IU Indianapolis Campus Indianapolis, Indiana For full-time staff employees, Indiana University offers a wide array of benefits including:

• Comprehensive medical and dental insurance;
• Health savings account with generous IU contributions;
• Healthcare and dependent care flexible spending accounts;
• Basic group life insurance paid by IU;
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance;
• Base retirement plan with generous IU contributions, subject to vesting;
• Voluntary supplemental retirement plan options;
• Tuition subsidy for employees and family members taking IU courses;
• Generous paid time off plans;
• Paid leave for new parents and IU-sponsored volunteer events;
• Employee assistance program (EAP).

Pay

Commensurate with experience.

Schedule

N/A