Clinical Data Coordinator (Clinical Research Technician)

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. 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.

Responsibilities

• 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

Education / Work Experience (combinations of related education and experience may be considered; education beyond the minimum may be substituted for work experience; work experience beyond the minimum may be substituted for education):

• 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

• 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

Pay

Career Level: Intermediate
FLSA: Nonexempt
Job Function: Research
Job Family: Clinical Research