Clinical Research Coordinator I, II, or III - Biltmore/Thunderbird Area

Clinical Research Coordinator III - Thunderbird Office

The Clinical Research Coordinator III is a senior-level coordinator responsible for executing multiple complex clinical trials from site initiation to close-out. Under the guidance of the Clinical Research Operations Manager, this role serves as a subject matter expert in protocol management, sponsor relations, and regulatory compliance. The CRC III mentors junior coordinators support internal audits and provides training and oversight to ensure protocol fidelity and operational excellence. This position requires strong clinical knowledge, leadership, and the ability to work independently across multiple research sites.

Essential Functions:

• Advanced Trial Coordination & Oversight
  • Independently coordinates all phases of multiple clinical trials simultaneously across various stages and locations.
  • Ensures study procedures comply strictly with protocol, GCP, and regulatory requirements.
  • Travels between study sites to support patient visits, conduct in-services, and facilitate sponsor visits.
  • Represent AKDHC at sponsor Investigator Meetings and training sessions, including out-of-state travel.
• Leadership & Mentorship
  • Acts as a lead coordinator and mentor to CRC I and II staff, providing hands-on training and protocol guidance.
  • Serve as back-up to the Clinical Research Operations Manager when needed.
  • Leads in-services and ongoing education for clinical staff and providers.
• Regulatory & Quality Oversight
  • Applies deep understanding of FDA CFR, ICH-GCP, and internal SOPs in daily trial conduct.
  • Assists in the development and execution of internal audits and in-house monitoring activities.
  • Maintains audit-ready study binders, data integrity, and proactive resolution of protocol deviations.
• Patient Engagement & Clinical Support
  • Educates patients on study requirements, kidney disease, dialysis, and the importance of research participation.
  • Conducts visits involving ECGs, vitals, specimen collection, phlebotomy, and medication administration under PI oversight.
  • Monitors for and reports adverse events per protocol and site SOP.

Skills Required:

• Excellent patient care skills
• Demonstrated application of medical knowledge and ability to understand and comply with protocol demands
• Positive work ethic & attitude
• Excellent communication skills (both written and verbal)
• Detail-oriented and problem-solving ability
• Ability to work with a team and handle multiple projects
• Ability to meet deadlines and multi-task without compromising quality
• Advanced knowledge of clinical trial operations and therapeutic area experience
• Strong leadership, mentorship, and training abilities
• Excellent organizational, data management, and documentation skills
• Ability to manage competing deadlines and lead multiple trials with minimal oversight
• Proficient in regulatory, EDC, CTMS, IRT, and clinical software
• Strong verbal and written communication, with demonstrated problem-solving skills

Job Specifications/Requirements:

• Bachelor's degree in life sciences, nursing, or related field required (or equivalent work experience)
• Clinical Research Coordinator Certification (e.g., ACRP, SOCRA) required
• Minimum 3+ years of clinical research experience with demonstrated ability to lead trials
• Experience training and mentoring junior team members
• Bilingual proficiency is considered a strong asset, though not required

Benefits:

We value our employees' time and efforts. Our commitment to your success is enhanced by our competitive compensation and extensive benefits package including paid time off, medical, dental and vision benefits, and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.