QUALIFICATIONS:
Required
- Active, unrestricted Advanced Practice license (NP or PA)
- Minimum of 2 years of experience as an Advanced Practice Provider or equivalent clinical role
- Minimum of 5 years nursing experience including home care or closely related service
- Clinical research experience as a Sub-Investigator or related research role. Minimum 1 year experience preferred
- Demonstrated experience in clinical leadership, supervision, or regional operations. Minimum 3 years management experience preferred
- Strong knowledge of GCP, ICH guidelines, HIPAA, and healthcare regulatory requirements
- Excellent communication, organizational, leadership, and critical-thinking skills
- Ability to travel regionally and nationally as required
- Proficiency with Microsoft Office Suite and electronic clinical research systems
Preferred
- Prior experience supporting multi-site or mobile clinical trials
- CITI, GCP, and IATA certifications
- Experience with performance improvement, budgeting, or regional operations
Core Competencies
- Clinical Research Execution & Compliance
- Operational & Regional Leadership
- Quality & Risk Management
- Patient- and Participant-Centered Care
- Data Integrity & Documentation Excellence
- Workforce Development & Coaching
- Cross-Functional Collaboration
Essential Functions/Areas of Accountability
Key Responsibilities
I. Clinical Research Execution & Sub-Investigator Responsibilities
- Serve as Sub-Investigator under delegated authority, supporting assigned Principal Investigators and virtual PIs in the conduct of clinical trials.
- Execute clinical trials in accordance with study protocols, GCP, ICH guidelines, federal and state regulations, and organizational SOPs.
- Perform pediatric, adult, and geriatric participant visits including medical history, medication reconciliation, physical exams, procedures, and education.
- Screen, prescreen, and confirm participant eligibility in compliance with HIPAA and protocol requirements.
- Administer investigational products, medications, vaccines, and perform clinical procedures (e.g., phlebotomy, ECGs, lab processing) within scope and delegation.
- Monitor, assess, document, and report adverse events, serious adverse events, protocol deviations, and safety findings in a timely manner.
- Support study start-up, vendor coordination, recruitment strategies, subject scheduling, regulatory documentation, data entry, query resolution, and study close-out activities.
- Ensure ALCOA+C documentation standards and data quality are consistently met.
- Participate in audits and inspections to ensure accuracy, integrity, and compliance of research data.
- Support community engagement and recruitment initiatives across diverse populations
II. Regional Clinical Operations Leadership
- Provide regional leadership and oversight for nurse-led clinical services and mobile health units.
- Direct, supervise, mentor, and develop Nurse Case Managers and clinical personnel to ensure safe, effective, and compliant care delivery.
- Oversee regional staffing models, productivity, scheduling, and workforce planning.
- Manage regional operational and fiscal performance in collaboration with administration.
- Ensure compliance with federal, state, and local healthcare regulations, Nurse Practice Acts, OSHA, and company policies.
- Ensure availability, maintenance, and safe operation of clinical supplies, equipment, and mobile units.
- Review clinical and operational documentation for accuracy, completeness, and timeliness in compliance with all applicable policies and regulations.
- Ensure 24-hour clinical coverage and appropriate on-call support where required.
- Develop and maintain strong relationships with community providers, referral sources, and regulatory entities.
III. Quality, Performance Improvement & Integration
- Lead and participate in performance improvement initiatives informed by research and operational data.
- Identify operational risks, compliance gaps, and opportunities for improvement and implement corrective actions.
- Collaborate with Quality, Compliance, Research, and Operations teams to align policies, procedures, and training.
- Analyze regional and research metrics to support continuous improvement in participant safety, data quality, and operational efficiency.
- Support feasibility assessments for new studies from both a clinical and operational perspective.
- Serve as a clinical and operational liaison between research teams and regional leadership.
Other Duties
- Perform other duties as aligned with organizational mission, vision, and values