The Clinical Research Coordinator plays a crucial role in managing clinical trials and research studies related to oncology. This position will also help the clinic to design workflows and monitor the GPRA quality measures.  This position works closely with the Medical Director, providers, researchers, regulatory bodies, and patients to ensure that clinical trials are conducted effectively, ethically, and in compliance with regulatory standards. This study coordinator will also work with the clinic and community in improving health outcomes including, but not limited to cancer screening, tobacco cessation, improvement of health quality metrics.

1. Coordinate and oversee all aspects of clinical trials from initiation through completion, including study design, implementation, and closeout.
2. Develop and maintain study documentation, including protocols, informed consent forms, and case report forms.
3. Identify and screen potential study participants, ensuring they meet eligibility criteria for trial enrollment.
4. Obtain informed consent from participants, and provide ongoing education about the study throughout their involvement.
5. Collect, record, and maintain accurate data related to the trial, including patient demographics, treatment regimens, and outcomes.
6. Ensure data integrity and compliance with regulatory requirements.
7. Work closely with oncologists, research teams, and other healthcare professional to facilitate study activities and resolve any issues that arise.
8. Monitor study progress and participant safety, reporting any adverse events or protocol violations promptly.
9. Prepare and submit regular reports on study status to stakeholders.
10. Stay updated on oncology research tends, clinical trial methodologies, and regulatory changes.
11. Assist with all cancer screening efforts in the clinic and participate in community events for cancer screening and tobacco cessation.
12. Design workflow to improve GPRA quality measures
13. Assist Medical Director with all tribal health related projects.
14. Because of the Tribe’s commitment to community service and the well being of its members, each employee may be expected to perform a wide range of office and field duties from time to time. Such duties may or may not be related to their regular responsibilities.

Required: Bachelor’s degree or equivalent experience, Minimum two to three years’ experience in a clinical research or cancer registry environment with regulatory or human research protections

Skilled In:

• Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
• Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.
• Proficiency is Microsoft Excel, including data entry, formatting and creating charts and tables.

Knowledge of:

• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Knowledge of how to synthesis study conduct.

Ability to:

• Ability to work with multiple data management systems including generating reports and sourcing data from systems.
• Ability to extract data from medical records
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
• Ability to develop and/or present content to internal team and external groups

While performing the duties of this job, the employee is frequently required to sit and talk or hear.  The employee is occasionally required to walk; use hands to operate, finger, handle, or feel objects, tools, or controls; and reach with hands and arms.  The employee must occasionally lift and/or move up to 30 pounds.  Specific vision abilities required by this job include close vision and the ability to adjust focus.  The noise level in the work environment is usually moderately quiet.