Hoosier Cancer Research Network Inc
CLINICAL RESEARCH MONITOR
Hoosier Cancer Research Network Inc, Indianapolis, Indiana, United States, 46278
Job Description
Job Description Description:
About Us Hoosier Cancer Research Network (HCRN) is at the forefront of advancing cancer research through collaborative, multi-institutional studies. Our work plays a pivotal role in developing innovative cancer treatments.
Your Role The Clinical Research Monitor plays a key role in evaluating the quality and compliance of oncology clinical trials conducted by HCRN’s national network of academic and community research sites. In this role, you will conduct ongoing site monitoring activities in accordance with Good Clinical Practice (GCP), federal regulations, and HCRN Standard Operating Procedures (SOPs). You will ensure accurate data collection, regulatory adherence, and protocol compliance at participating sites, working closely with Project Managers, Data Management, and Regulatory teams to support safe and effective trial execution. This position requires regular travel to clinical sites and is ideal for individuals who are detail-oriented, knowledgeable about clinical research, and motivated to contribute to high-quality cancer trials.
Key Responsibilities Site Qualification and Monitoring · Perform routine and for-cause site monitoring visits based on HCRN’s Data Safety Oversight Process (DSOP) · Review source documents and case report forms to verify accuracy and data integrity · Evaluate protocol compliance, regulatory documentation, informed consent records, and investigational product accountability · Identify, document, and follow up on findings, deviations, or site performance issues Communication and Coordination · Communicate visit findings and recommended actions to site staff and internal study teams · Collaborate with Project Managers, Regulatory, and Data Management to address issues · Provide clarification to sites on protocol requirements, documentation expectations, and monitoring outcomes Training and Site Support · Deliver protocol-specific training and coaching to site personnel during visits · Reinforce regulatory, documentation, and investigational product handling standards · Share best practices for protocol adherence and high-quality data collection Documentation and Reporting · Complete monitoring reports in the electronic data capture (EDC) system following each visit · Maintain timely and accurate documentation of monitoring activities, communications, and follow-ups Requirements:
What You Bring · Bachelor’s degree in life sciences, healthcare, or related field · Minimum 2 years of experience in clinical research (oncology preferred) · Familiarity with Good Clinical Practice (GCP), FDA regulations, and HIPAA · Strong communication skills (written and verbal) · Excellent attention to detail, time management, and organizational skills · Proficiency in Microsoft Office; experience with clinical trial platforms and EDC systems preferred · Ability and willingness to travel frequently, including overnight visits to sites across the U.S.
Knowledge Skills and Abilities (KSAs) · Site monitoring and qualification practices · Application of GCP and regulatory guidelines · Source data review and verification accuracy · Monitoring report preparation and issue tracking · Clear and professional communication with internal and external teams
Core Competencies · Clinical Research Knowledge · Ownership and Follow-through · Critical Thinking and Initiative
Work Style & Expectations · Regular check-ins with the Assistant Director of Data Management · Ability to work both independently and collaboratively in a fast-paced environment · Comfort with frequent travel and site-based work
Work Environment · Reports to: Assistant Director of Data Management · Direct Reports: none · Status: Exempt / 40+ hours/week · Office Location: Remote or Hybrid (with travel to clinical sites as needed) · Travel: 50-70%
Other Duties Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Why Join Us At HCRN, you’ll help ensure the integrity and safety of oncology clinical trials while supporting cutting-edge cancer research. As a Clinical Research Monitor, you’ll play a vital role in maintaining the quality and compliance of studies that can shape the future of cancer care.
HCRN grants equal opportunity to all qualified persons without regard to race, color, religion, gender, pregnancy, disability, age, national origin, military service obligations, veteran status, citizenship, sexual orientation, or any other category protected by law. HCRN provides equal opportunity in wages, promotions, benefits, and all other privileges, terms, and conditions of employment. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Job Description Description:
About Us Hoosier Cancer Research Network (HCRN) is at the forefront of advancing cancer research through collaborative, multi-institutional studies. Our work plays a pivotal role in developing innovative cancer treatments.
Your Role The Clinical Research Monitor plays a key role in evaluating the quality and compliance of oncology clinical trials conducted by HCRN’s national network of academic and community research sites. In this role, you will conduct ongoing site monitoring activities in accordance with Good Clinical Practice (GCP), federal regulations, and HCRN Standard Operating Procedures (SOPs). You will ensure accurate data collection, regulatory adherence, and protocol compliance at participating sites, working closely with Project Managers, Data Management, and Regulatory teams to support safe and effective trial execution. This position requires regular travel to clinical sites and is ideal for individuals who are detail-oriented, knowledgeable about clinical research, and motivated to contribute to high-quality cancer trials.
Key Responsibilities Site Qualification and Monitoring · Perform routine and for-cause site monitoring visits based on HCRN’s Data Safety Oversight Process (DSOP) · Review source documents and case report forms to verify accuracy and data integrity · Evaluate protocol compliance, regulatory documentation, informed consent records, and investigational product accountability · Identify, document, and follow up on findings, deviations, or site performance issues Communication and Coordination · Communicate visit findings and recommended actions to site staff and internal study teams · Collaborate with Project Managers, Regulatory, and Data Management to address issues · Provide clarification to sites on protocol requirements, documentation expectations, and monitoring outcomes Training and Site Support · Deliver protocol-specific training and coaching to site personnel during visits · Reinforce regulatory, documentation, and investigational product handling standards · Share best practices for protocol adherence and high-quality data collection Documentation and Reporting · Complete monitoring reports in the electronic data capture (EDC) system following each visit · Maintain timely and accurate documentation of monitoring activities, communications, and follow-ups Requirements:
What You Bring · Bachelor’s degree in life sciences, healthcare, or related field · Minimum 2 years of experience in clinical research (oncology preferred) · Familiarity with Good Clinical Practice (GCP), FDA regulations, and HIPAA · Strong communication skills (written and verbal) · Excellent attention to detail, time management, and organizational skills · Proficiency in Microsoft Office; experience with clinical trial platforms and EDC systems preferred · Ability and willingness to travel frequently, including overnight visits to sites across the U.S.
Knowledge Skills and Abilities (KSAs) · Site monitoring and qualification practices · Application of GCP and regulatory guidelines · Source data review and verification accuracy · Monitoring report preparation and issue tracking · Clear and professional communication with internal and external teams
Core Competencies · Clinical Research Knowledge · Ownership and Follow-through · Critical Thinking and Initiative
Work Style & Expectations · Regular check-ins with the Assistant Director of Data Management · Ability to work both independently and collaboratively in a fast-paced environment · Comfort with frequent travel and site-based work
Work Environment · Reports to: Assistant Director of Data Management · Direct Reports: none · Status: Exempt / 40+ hours/week · Office Location: Remote or Hybrid (with travel to clinical sites as needed) · Travel: 50-70%
Other Duties Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Why Join Us At HCRN, you’ll help ensure the integrity and safety of oncology clinical trials while supporting cutting-edge cancer research. As a Clinical Research Monitor, you’ll play a vital role in maintaining the quality and compliance of studies that can shape the future of cancer care.
HCRN grants equal opportunity to all qualified persons without regard to race, color, religion, gender, pregnancy, disability, age, national origin, military service obligations, veteran status, citizenship, sexual orientation, or any other category protected by law. HCRN provides equal opportunity in wages, promotions, benefits, and all other privileges, terms, and conditions of employment. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.