Clinical Research Associate - Oncology

Trinity Health • Grove City, OH

6h

About The Position

The Clinical Research Associate (Oncology) coordinates and manages oncology clinical research studies to support the safe, ethical, and compliant conduct of clinical trials. The role facilitates study start-up, participant 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, Institutional Review Board (IRB) policies, and organizational policies. The associate serves as a liaison among research participants, investigators, sponsors, contract research organizations, and multidisciplinary healthcare teams. Through study coordination, data integrity management, and participant advocacy, the position supports cancer research, clinical innovation, and improved patient outcomes.

The position supports studies from start-up through closeout, including participant recruitment and visits, regulatory submissions and records, data entry and quality, protocol compliance, safety reporting, and communication with study stakeholders. It also supports feasibility and site activation, enrollment initiatives, reporting, quality assurance, audits, inspections, and process improvement. The role promotes participant safety, ethical research conduct, confidentiality, and patient advocacy throughout clinical trial participation.

Requirements

• Bachelor's degree in biological sciences, health sciences, or a medical field.
• CITI research ethics training is required; on-site training is provided.
• Two to four years of clinical research experience is required.
• Effective communication skills.
• Knowledge of research regulatory and data management requirements.
• Ability to work independently.
• Strong time management skills.

Nice To Haves

• Oncology clinical research experience is preferred.
• Experience using electronic data capture (EDC) systems is preferred.

Responsibilities

• Coordinate and manage assigned oncology clinical trials from study start-up through closeout, ensuring compliance with protocols, 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 GCP guidelines.
• Prepare and submit regulatory documents, protocol amendments, continuing reviews, adverse event reports, and study-related correspondence to the IRB.
• Monitor participant compliance with study protocols and identify, document, and report protocol deviations.
• 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 about study requirements, procedures, timelines, and compliance expectations.
• Protect participant health information in accordance with HIPAA and applicable privacy regulations.
• Collaborate with multidisciplinary healthcare teams to facilitate protocol adherence and optimize participant care during study participation.
• Support study feasibility assessments, site activation activities, and enrollment initiatives.
• 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 clinical trial execution.
• Perform other research-related duties as assigned to support departmental and organizational research objectives.

Benefits

• Medical, dental, and vision coverage starting on day one.
• Retirement savings account with employer match starting on day one.
• Paid time off programs.
• Employee recognition programs.
• Tuition and professional development reimbursement starting on day one.
• RN-to-BSN tuition fully paid at Mount Carmel’s College of Nursing.
• Relocation assistance, subject to geographic and position restrictions.
• Employee Referral Rewards program.
• DailyPay access for eligible colleagues.
• Diversity, Equity, and Inclusion Colleague Resource Groups.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level