Hybrid Certified Registered Nurse Practitioner CRC

The Hybrid CRNP/Clinical Research Coordinator is responsible for providing direct patient care as an Advanced Practice Provider while coordinating and managing clinical research studies in accordance with protocol requirements Good Clinical Practice (GCP) guidelines sponsor expectations and regulatory requirements. This role bridges clinical care and research operations to ensure high-quality patient outcomes protocol compliance and successful study execution.

• Conduct comprehensive patient assessments including medical histories and physical examinations.
• Diagnose and manage acute and chronic medical conditions within the CRNP scope of practice.
• Develop and implement treatment plans.
• Order interpret and review diagnostic tests and laboratory results.
• Prescribe medications and therapeutic interventions in accordance with state regulations and collaborating physician agreements.
• Provide patient education regarding disease management medications wellness and preventive healthcare.
• Document patient encounters accurately and timely in the electronic medical record (EMR).
• Collaborate with physicians nurses and other healthcare professionals to deliver coordinated care.
• Participate in quality improvement initiatives and patient safety activities.

• Serve as primary coordinator for clinical trials from study startup through closeout.
• Screen recruit and enroll eligible research participants.
• Conduct informed consent discussions and ensure proper documentation.
• Schedule and coordinate protocol-required study visits.
• Collect review and document study-related clinical data.
• Process and ship laboratory specimens according to protocol requirements.
• Maintain source documentation and regulatory binders.
• Ensure compliance with FDA regulations ICH-GCP guidelines HIPAA requirements and institutional policies.
• Report adverse events protocol deviations and safety concerns promptly.
• Coordinate monitoring visits audits and sponsor communications.
• Assist Principal Investigators with study feasibility assessments and site selection activities.
• Enter and reconcile data in electronic data capture (EDC) systems.
• Track recruitment metrics and study performance indicators.
• Support budget review and study startup processes as needed.

• Current Certified Registered Nurse Practitioner (CRNP) license in Alabama (or applicable state).
• Masters or Doctoral degree in Nursing.
• Current DEA registration and prescriptive authority.
• Minimum 2 years of clinical practice experience.
• Minimum 1 year of clinical research experience or equivalent research exposure.
• Knowledge of GCP FDA regulations and human subject protection requirements.
• Strong organizational and project management skills.
• Proficiency with EMR and Microsoft Office applications.
• Excellent communication and interpersonal skills.

• Certification as a Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).
• Experience in industry-sponsored clinical trials.
• Therapeutic area experience in nephrology oncology cardiology endocrinology gastroenterology or vaccines.
• Experience with EDC systems such as Medidata Rave Veeva or Oracle Inform.

• Patient-centered care
• Clinical judgment and decision-making
• Attention to detail
• Regulatory compliance
• Time management
• Leadership and collaboration
• Problem-solving
• Ability to manage multiple studies simultaneously

• Ability to stand walk and sit for extended periods.
• Ability to occasionally lift and move up to 25 pounds.
• Dexterity required for clinical procedures data entry and specimen handling.

• Hybrid role combining direct patient care and research operations.
• Work performed in outpatient clinic and research settings.
• Occasional travel for investigator meetings training or conferences may be required.

• Reports to: Medical Director / Research Site Director
• Collaborates with: Principal Investigators Sub-Investigators Clinical Research Associates Research Staff Medical Assistants and Administrative Personnel