Medasource
Clinical Research Coordinator (Indianapolis)
Medasource, Indianapolis, Indiana, United States, 46262
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 experience OR
Associates 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.
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 experience OR
Associates 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.