Clinical Research Associate - Oncology

Mount Carmel Health System is hiring a Clinical Research Associate (Oncology) to coordinate oncology clinical trials from study start-up through closeout. The role supports participant recruitment and care, regulatory compliance, data integrity, and collaboration among investigators, sponsors, research participants, and healthcare teams.

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Responsibilities

• Coordinate and manage assigned oncology clinical trials from study start-up through closeout, ensuring compliance with protocol requirements, regulatory standards, and organizational policies
• Screen, recruit, and refer eligible research participants to care providers in accordance with study protocols and informed consent requirements
• Coordinate participant visits, assessments, treatments, laboratory testing, and follow-up activities required by research protocols
• Serve as a primary liaison among investigators, research participants, sponsors, contract research organizations (CROs), and internal clinical departments
• Collect, review, verify, and enter clinical research data into electronic data capture systems, ensuring accuracy, completeness, and timeliness
• Maintain study documentation, regulatory binders, investigator site files, and essential study records in accordance with Good Clinical Practice (GCP) guidelines
• Prepare and submit required regulatory documents, protocol amendments, continuing reviews, adverse event reports, and study-related correspondence to the Institutional Review Board (IRB)
• Monitor participant compliance with study protocols and identify, document, and report protocol deviations as required
• Track and resolve data queries, discrepancies, and missing information to maintain data integrity and study quality
• Assist investigators in identifying and reporting adverse events, serious adverse events, and other safety-related findings according to protocol and regulatory requirements
• Educate participants and clinical staff regarding study requirements, procedures, timelines, and compliance expectations
• Ensure confidentiality and protection of participant health information in accordance with HIPAA and applicable privacy regulations
• Collaborate with multidisciplinary healthcare teams to facilitate protocol adherence and optimize participant care throughout study participation
• Support study feasibility assessments, site activation activities, and enrollment initiatives to expand oncology research opportunities
• Prepare study updates, enrollment reports, and performance metrics for investigators, sponsors, and organizational leadership
• Participate in quality assurance activities, audits, inspections, and process improvement initiatives related to clinical research operations
• Maintain current knowledge of oncology research practices, regulatory requirements, GCP standards, and emerging clinical trial methodologies
• Promote participant safety, ethical research conduct, and patient advocacy throughout all phases of clinical trial execution
• Perform other research-related duties as assigned to support departmental and organizational research objectives

Preferred

• oncology preferred
• Experience using Electronic Data Capture (EDC) systems preferred

Benefits

• Medical, dental, and vision coverage starting on day one.
• Retirement savings account with employer match starting on day one.
• Generous paid time off programs.
• Employee recognition programs.
• Tuition/professional development reimbursement starting on day one.
• RN to BSN tuition 100% paid at Mount Carmel’s College of Nursing.
• Relocation assistance (geographic and position restrictions apply).
• Employee Referral Rewards program.
• DailyPay for eligible colleagues, allowing them to see how much they’ve made each day and transfer money any time before payday.
• Opportunity to join Diversity, Equity, and Inclusion Colleague Resource Groups.
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• Trinity Health is one of the largest multi-institutional Catholic health care delivery systems in the nation.
• Livonia, Michigan, USA
• http://www.trinity-health.org
• Distribution of Different Job Fields Receiving Sponsorship
• Represents job field similar to this job
• Engineering and Development
• Customer Service and Support
• Education and Training
• Accounting and Finance
• Management and Executive
• Trends of Total Sponsorships
• *2026
• (16)
• 2025
• (9)
• 2024
• (12)

Qualifications

• Education: Bachelor's degree in biological sciences, health sciences, or medical field
• CITI research ethics training required (on-site training provided)
• Two (2) to four (4) years of experience in clinical research required
• Effective communication skills, knowledge of research regulatory and data management requirements, ability to work independently, and strong time management skills
• Oncology preferred
• Experience using Electronic Data Capture (EDC) systems preferred

Required skills

• Clinical Research, Oncology Research, CITI Research Ethics Training, Electronic Data Capture (EDC) Systems, Clinical Research Regulatory Requirements, Clinical Research Data Management

Preferred skills

• oncology preferred

Experience

• 2-4 years