Job Description

Job Description

Clinical Research Coordinator (CRC)

Location: Indianapolis

Duration: 6+ month contract

Schedule: Monday–Friday, ~40 hours/week (some flexibility based on clinic or study needs)

Role Overview

Coordinates both sponsor-initiated and investigator-initiated oncology-focused clinical trials. Responsible for identifying, screening, and enrolling eligible participants; ensuring compliance with study protocols; and serving as the primary liaison between the study team, participants, and sponsors.

Key Responsibilities

Study Coordination & Participant Management

• Screen and identify potential study participants by reviewing medical records against protocol eligibility criteria.
• Obtain informed consent from study participants and ensure all documentation is properly completed before study initiation.
• Schedule and coordinate research-related services such as infusions, imaging, and other procedures.
• Collaborate with insurance coordinators and research nurses to confirm coverage for standard-of-care procedures.
• Maintain participant scheduling, visit confirmation, and reimbursement tracking through OnCore and Nimblify.

Data Collection & Regulatory Compliance

• Conduct study visits, including interviews and assessments related to medication compliance, quality of life, and adverse events.
• Record and document protocol deviations and collaborate with the study team to resolve any issues.
• Extract and enter data from source documents into case report forms and assist with SAE reporting.
• Ensure compliance with GCP standards, IRB, FDA, and institutional regulations.

Team & Sponsor Collaboration

• Coordinate with sponsors, clinical research specialists, and investigators to ensure study integrity and resolve queries.
• Prepare for monitoring visits and participate in teleconferences and investigator meetings.
• Educate ancillary departments and staff on protocol requirements and assist in the development of study-specific order sets.

Administrative & Operational Support

• Maintain accurate records, calendars, and participant statuses in OnCore.
• Contribute to SOPs, site policies, and process improvements to enhance research operations.
• Provide direction and oversight to Clinical Research Specialists (CRS), Clinical Data Coordinators (CDC), and lab technicians.

Qualifications

Education:

• Bachelor’s degree in science or a health-related field and at least 2 years of clinical research experience
• OR Associate’s degree in science or a health-related field and 3 years of clinical research experience
• Preferred: SOCRA or ACRP Clinical Research Certification

Skills & Abilities:

• Strong organizational and communication skills (written and verbal)
• Ability to interpret complex scientific and clinical information
• Proficient in OnCore and Microsoft Office
• Strong attention to detail and ability to multitask in a fast-paced clinical setting
• Excellent interpersonal skills with the ability to interact with participants, families, and multidisciplinary teams
• Knowledge of research documentation, case report forms, and study protocols

Additional Notes

• This position functions autonomously and requires regular interaction with principal investigators and study staff.
• The role is critical to participant safety and protocol compliance; attention to regulatory standards is essential.
• Physical requirements include working in clinic settings, sitting for extended periods, and maintaining composure in a fast-paced environment.

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