Job Description

Employment Type:

Full time

Shift:

Day Shift

Description:

The Clinical Research Associate (Oncology) is responsible for coordinating and managing oncology clinical research studies to ensure the safe, ethical, and compliant conduct of clinical trials. This role facilitates study start-up, patient screening and enrollment, protocol implementation, data collection, regulatory documentation, and ongoing study oversight in accordance with federal regulations, Good Clinical Practice (GCP) guidelines, sponsor requirements, and Institutional Review Board (IRB) policies. The Clinical Research Associate serves as a key liaison among research participants, investigators, sponsors, and multidisciplinary healthcare teams to support the successful execution of oncology research protocols. Through effective study coordination, data integrity management, and participant advocacy, this position contributes to the advancement of cancer care, clinical innovation, and organizational research objectives.

Position Purpose

The Clinical Research Associate (Oncology) supports the successful execution of oncology clinical research studies by coordinating study activities, ensuring regulatory compliance, and maintaining the integrity of research data. This role works collaboratively with investigators, research participants, sponsors, and multidisciplinary healthcare teams to facilitate patient recruitment, protocol implementation, data collection, and study oversight. The Clinical Research Associate helps ensure that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, federal regulations, Institutional Review Board (IRB) requirements, and organizational policies while promoting participant safety, research quality, and ethical standards. Through effective study coordination and operational support, this position contributes to the advancement of cancer research, innovative treatment options, and improved patient outcomes.

Job Qualifications

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

Essential 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.

Position Highlights and Benefits:

· Mount Carmel Health System recognized by Forbes in 2025 as one of America’s Best State Employers.

· Competitive compensation and benefits packages including medical, dental, and vision with 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.

· Mount Carmel offers DailyPay - if you’re hired as an eligible colleague, you’ll be able to see how much you’ve made every day and transfer your money any time before payday. You deserve to get paid every day!

· Opportunity to join Diversity, Equity, and Inclusion Colleague Resource Groups.

Ministry/Facility Information:

Mount Carmel, a member of Trinity Health, has been a transforming healing presence in Central Ohio for over 135 years. Mount Carmel serves over 1.3 million patients each year at our five hospitals, free-standing emergency centers, outpatient facilities, surgery centers, urgent care centers, primary care and specialty care physician offices, community outreach sites and homes across the region. Mount Carmel College of Nursing offers one of Ohio's largest undergraduate, graduate, and doctor of nursing programs. If you’re seeking a rewarding career where your purpose, passion, and desire to make a difference come alive, we invite you to consider joining our team. Here, care is provided by all of us For All of You!

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.