Oncology Clinical Research Coordinator

Job Overview
We are seeking a dedicated and energetic Oncology Clinical Research Coordinator to join our dynamic research team. In this vital role, you will coordinate and oversee clinical trials focused on cancer treatments, ensuring adherence to regulatory standards and protocol requirements. Your expertise will help advance innovative therapies and improve patient outcomes. This position offers an exciting opportunity to be at the forefront of oncology research, working closely with multidisciplinary teams, patients, and regulatory bodies to facilitate high-quality clinical studies. The ideal candidate will bring a proactive attitude, excellent organizational skills, and a passion for clinical research excellence.

Duties

• Coordinate all aspects of oncology clinical trials, including patient recruitment, enrollment, and follow-up care in compliance with study protocols and regulatory guidelines.
• Review and verify study documentation such as informed consent forms, case report forms, and medical records to ensure accuracy and completeness.
• Monitor patient progress through regular assessments of vital signs, blood sampling (phlebotomy), and other clinical procedures aligned with study protocols.
• Manage data collection, entry, and management using electronic medical record (EMR) systems and adhere to data standards such as CDISC (Clinical Data Interchange Standards Consortium).
• Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and other applicable regulatory requirements throughout the trial process.
• Supervise research staff and coordinate with nurses, laboratory personnel, and external vendors to facilitate smooth trial operations.
• Conduct clinical laboratory procedures related to blood sampling and analyze results using appropriate statistical software for data interpretation.
• Review source documents meticulously for accuracy while maintaining strict confidentiality of patient information.
• Facilitate training sessions on GCP standards, protocol adherence, and documentation review for team members.
• Prepare reports for regulatory submissions and audit readiness while maintaining detailed records of all trial activities.
• Traveling between sites will be required (Spring/Woodlands, Kingwood, Tomball and rarely, Huntsville)

Skills

• Proven experience in a clinical research environment-bonus if oncology trial experience.
• Extensive knowledge of clinical trials management, including protocol development and regulatory compliance.
• Strong understanding of medical terminology, blood sampling techniques (phlebotomy), vital signs measurement, and clinical laboratory procedures.
• Proficiency in data collection tools, EMR systems, statistical software, and adherence to CDISC standards for data management.
• Familiarity with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and compliance management practices.
• Experience reviewing documentation such as informed consent forms and source documents for accuracy and completeness.
• Ability to monitor patients effectively during trials while ensuring safety and adherence to protocols.
• Clinical development experience within oncology or related fields is highly desirable.
• Certification in Good Clinical Practice (GCP) from a recognized issuer such as the CA (California) or equivalent is required; ICH GCP certification is preferred.
• Strong analysis skills with the ability to interpret complex data sets related to clinical outcomes.
• Excellent organizational skills with attention to detail in documentation review and data management tasks. Join us in advancing groundbreaking cancer therapies! We are committed to fostering an inclusive environment where your expertise can make a real difference in patients’ lives while supporting your professional growth through comprehensive training programs and collaborative teamwork.

Pay: $28.00 - $35.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Education:

• High school or equivalent (Required)

Experience:

• Internal Medicine or Oncology: 3 years (Preferred)

Willingness to travel:

• 25% (Required)

Work Location: In person