Clinical Research Coordinator (CRC)
Location : Indianapolis
Duration : 6+ month contract
Schedule : MondayFriday, ~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 :
Bachelors degree in science or a health-related field and at least 2 years of clinical research experienceOR Associates degree in science or a health-related field and 3 years of clinical research experiencePreferred : SOCRA or ACRP Clinical Research CertificationSkills & Abilities :
Strong organizational and communication skills (written and verbal)Ability to interpret complex scientific and clinical informationProficient in OnCore and Microsoft OfficeStrong attention to detail and ability to multitask in a fast-paced clinical settingExcellent interpersonal skills with the ability to interact with participants, families, and multidisciplinary teamsKnowledge of research documentation, case report forms, and study protocolsAdditional 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.