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.
Job Tags
Contract work, Work at office, Monday to Friday,