Clinical Research Coordinator - Oncology

Job Summary:

The Clinical Research Coordinator II will oversee clinical trial regulatory matters and research studies within the Oncology Center. This role involves coordinating all aspects of clinical research, including study design, protocol development, patient recruitment, regulatory compliance, data collection, and analysis. The Clinical Research Coordinator II will work closely with principal investigators, clinical staff, and external partners to ensure the success of ongoing and upcoming oncology research projects and should be well-versed in clinical trial regulatory requirements.

Key Responsibilities

1. Study intake, Oversight & Coordination: - Oversee multiple oncology clinical trials, ensuring adherence to study protocols and timelines. - Oversee study intake process, regulatory requirements, and approvals for studies - Collaborate with the sponsors, research team, physicians, and other clinical staff to facilitate the smooth conduct of trials. - Ensure proper documentation and reporting of trial-related activities.

2. Regulatory Compliance: - Maintain compliance with all federal, state, and institutional regulations regarding clinical research, including GCP (Good Clinical Practice) and FDA guidelines. - Oversee the submission of protocols, amendments, and reports to the Institutional Review Board (IRB) and regulatory agencies. - Ensure proper consent processes are followed, and all patient rights are protected.

3. Patient Recruitment: - Lead patient recruitment efforts, working with the clinical team to identify eligible participants for oncology trials. - Provide education and support to patients and families about the research study and ensure informed consent is obtained.

- Monitor patient safety, treatment adherence, and follow-up throughout the study.

4. Data Management & Reporting: - Ensure accurate and timely collection, entry, and analysis of clinical data. - Collaborate with data management teams to ensure data integrity and quality assurance. - Prepare and present study updates and outcomes to investigators and stakeholders.

5. Team Collaboration:

- Responsible for coordinating with other clinical research coordinators within your department.

- Maintain ongoing training and education on research protocols, regulatory updates, and clinical practices.

- Serve as a liaison between clinical staff, sponsors, and external partners, ensuring clear communication and collaboration.

6. Budget & Resource Management: - Assist in the development of study budgets and financial tracking for clinical trials. - Oversee the allocation of resources, including staff, equipment, and study materials, to support clinical research activities.

7. Continuous Improvement: - Stay updated on new developments in oncology research and clinical trial methodologies. - Identify opportunities for process improvements to increase the efficiency and quality of clinical trials. Qualifications:

8. Required Qualifications: Bachelor’s degree in life sciences, nursing, or related field (Master’s degree or PhD preferred).

2-5 years of regulatory experience in clinical trials (a focus on oncology is a plus).

Knowledge of FDA regulations, GCP guidelines, and clinical trial processes, particularly in oncology settings.

Strong organizational and leadership skills. Ability to manage multiple projects and timelines concurrently. Excellent communication skills, both written and verbal. Proficiency in clinical trial management software and electronic data capture (EDC) systems. Proficiency in Real Time Clinical Management software.

9. Preferred Qualifications: Certification from an industry-recognized organization such as ACRP or SOCRA. Experience working in early-phase (Phase I/II) oncology trials or immuno-oncology is a plus. Familiarity with electronic data capture (EDC) systems and oncology-specific databases.

Job Type: Full-time

Pay: $ 22.03- $32.04 per hour. Benefits: Health insurance, retirement benefits, vacation time, company holidays, free parking

Medical Specialty: Oncology Schedule: 8-hour shift Day shift.

Experience:

1. Documentation review: 2 years (Required)

2. Data management: 2 years (Required)

Contact: KiranC@nextgenonc.com

Pay: $22.03 - $35.04 per hour

Benefits:

• 401(k)
• Health insurance
• Paid time off

Work Location: In person