Clinical Data Coordinator (Clinical Research Technician)

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. 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.

Job Summary

• Assists in the conduct of clinical research studies or trials following established protocols and standard operating procedures (SOP).
• Assists with identifying and recruiting subjects for clinical research studies or trials; calls/schedules subjects for appointments per protocol; performs screening, consenting and interviewing/data collection in adherence with the assigned study protocol and in accordance with good clinical principals (GCP); collects patient consent and authorization for treatment intervention documents and performs those interventions as needed.
• Conducts routine experiments and/or coordinates research study procedures in accordance with SOPs; receives, collects, and records study data in database; communicates and keeps researchers and/or principal investigator (PI) up-to-date on any problems or concerns related to the research study or trial; may be responsible for collecting clinical samples (such as blood, sample tissue, etc.) for research including any storage measures.
• Assists with advertising and other information for participant recruitment; assists in developing and sharing educational and informational resources with subjects and families.
• Ensures proper documentation of Case Report Forms, regulatory documents, PI notes, and any other mandatory study-related documents and ensures quality and accuracy; archives documents for study per sponsor, government and institutional requirements; keeps accurate records and provides necessary documents for regulatory audits.
• Maintains and manages inventory and research study supplies; may be responsible for facilitating disbursement of study participant payments.
• Provides various additional research study support (such as protocol research in medical library/online databases, summarizing literature reviews for study hypothesis, grant preparation, manuscript review/editing, literature searches, and/or transcription).
• Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.

Qualifications

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION / WORK EXPERIENCE

Required

• High school diploma or equivalent (such as HSED or GED) plus 5 years patient-related or research experience that includes 2 years of experience with clinical studies; OR
• Associate's degree in allied health profession plus 1 year of patient-related or research experience; OR
• Bachelor's degree in any field or 3 years of college-level science plus 2 years of patient-related or research experience; OR
• Bachelor's degree in science or health-related field

SKILLS

Required

• Proficient written and verbal communication skills
• Maintains a high degree of professionalism
• Demonstrates time management and priority setting skills
• Demonstrates a high commitment to quality
• Possesses flexibility to work in a fast paced, dynamic environment
• Highly thorough and dependable

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.

Work Location

IUSCCC Clinical Trials Office

IU Indianapolis Campus

Indianapolis, Indiana

Benefits Overview

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
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure .

Job Classification

Career Level: Intermediate

FLSA: Nonexempt

Job Function: Research

Job Family: Clinical Research

Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

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.

If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Equal Employment Opportunity

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information .

Campus Safety and Security

The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at [click to reveal email address] View email address on us.fitly.work or by visiting IUPD.

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