Clinical Research Coordinator

American Oncology Partners, PA; United States; On-site; USD 32,855 - 57,804; Full time

Benefits offered by this job

Comprehensive health insurance

401(k) with 100% match

Paid time off

Flexible work options

Job summary

American Oncology Partners, PA is seeking a Clinical Research Coordinator II for the Woodlands Cancer Institute. This role involves managing research studies under the supervision of a Principal Investigator, ensuring compliance with protocols and regulatory requirements.

Candidates should have 2–5 years of oncology research experience and strong analytical, communication, and problem-solving skills. The position offers competitive pay, comprehensive health insurance, 401(k) with 100% match, and flexible work options.

Qualifications

• 2–5 years of prior oncology research or related medical science experience required.
• Demonstrated critical thinking and analysis skills.
• Proficiency in MS Office and familiarity with clinical research tools.

Responsibilities

• Coordinate care for patients on clinical research protocols.
• Ensure compliance with regulatory guidelines.
• Manage study budgets and financial practices.

Skills

Analytical skills

Communication skills

Problem-solving

Time management

Education

Bachelor's degree preferred

High school education required

Licensed Practical Nurse required

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

EMR

EDC

CTMS systems

Job description

Job Summary

Location: Woodlands Cancer Institute
Pay Range: $23.85 - $41.96

Clinical Research Coordinator II (non‑RN). Responsible for the performance of research studies under the medical supervision of the Principal Investigator. Performs tasks independently, consistently, and accurately, demonstrating a moderate level of expertise in all required skills and abilities, resulting in high‑quality work.

Key Performance Areas

KPA 1 – Protocol Comprehension and Implementation

• Coordinate care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines, and regulatory requirements.
• Understand protocol elements and execute study procedures accurately.
• Anticipate and mitigate protocol non‑compliance, conducting feasibility assessments and completing site assessment questionnaires.
• Assess subject eligibility based on inclusion/exclusion criteria and independently document eligibility.
• Review draft informed consent documents for regulatory compliance and conduct informed consent discussions.
• Review and interpret diagnostic test results as required by the protocol.
• Capture, assess, and report adverse events, determining their causal relationship to the investigational product and following up appropriately.
• Maintain accurate records of receipt, inventory, distribution, and destruction of study‑related materials and investigational products.
• Ensure proper storage of investigational drugs and return excess materials to sponsors per guidelines, managing compromised products.

KPA 2 – Regulatory and Data Integrity

• Understand IRB/IEC review processes and key review considerations, approval, and reporting requirements.
• Complete all IRB/IEC‑related documents throughout a clinical study and maintain site credentials, GCP certificates, and licenses on file.
• Report safety‑related subject discontinuation and any adverse events to sponsors and IRB/IEC.
• Autonomously collect, record, and report accurate data in accordance with FDA guidelines, ensuring scientific integrity and data completeness.
• Manage monitoring visits, including preparation, documentation, and follow‑up, and communicate with monitors in a timely manner.
• Implement CAPA assessments and resolve CAPA‑related issues, escalating protocol non‑compliance to the PI and research department leadership.

KPA 3 – Research Financial Practices

• Assess protocols and study plans to develop study budgets and understand payment terms and invoicing items for clinical studies.
• Ensure research billing compliance and manage contract execution and financial practices.

Position Qualifications / Requirements

• Education: High school education required; some college required; bachelor's degree preferred; Licensed Practical Nurse required.
• Experience: 2–5 years of prior oncology research or related medical science experience.
• Core Capabilities:
  • Analysis & critical thinking skills, problem solving, decision‑making, planning, time management.
  • Interpersonal effectiveness: diplomacy, conflict management, diversity awareness.
  • Communication skills: effective oral, written, and presentation skills.
  • Customer service and organizational awareness: build a quality culture and strong stakeholder relationships.
  • Self‑management: manage time, priorities, and professional development independently.
• Computer Skills: Proficiency in MS Office (Word, Excel, PowerPoint, Outlook). Preferred experience with EMR, EDC, and CTMS systems.
• Travel: 0%
• Work Hours: Monday to Friday, 8:00AM – 5:00PM.

Benefits

Competitive compensation package including comprehensive health insurance, 401(k) with 100% match, and paid time off. Flexible work options available.