Clinical Research Associate - Oncology

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: see how much you’ve made every day and transfer your money any time before payday.

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

Glassdoor

3.6

Mount Carmel Health System is a hospital & health care company & provides the best in people-centered care.

Columbus, Ohio, USA

https://www.mountcarmelhealth.com/

Late Stage

Leadership Team

Lorraine Lutton

President and CEO

Tauana McDonald

President & Chief Executive Officer

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Qualifications

Bachelor's degree in biological sciences, health sciences, or medical field

CITI research ethics training required

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

Preferred skills

oncology preferred

Experience

2-4 years