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.

Essential Duties and Responsibilities

Clinical Practice Responsibilities (50%)

• 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.

Clinical Research Responsibilities (50%)

• 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.

Qualifications

Required

• Current Certified Registered Nurse Practitioner (CRNP) license in Alabama (or applicable state).
• Master's 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.

Preferred

• 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.

Competencies

• 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

Physical Requirements

• 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.

Work Environment

• 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.

Reporting Structure

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