Regional Director, Clinical Operations and Research (NPPA)

Farmington, NM - USA

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

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 ALCOAC 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

Required Experience:

Director

QUALIFICATIONS:RequiredActive unrestricted Advanced Practice license (NP or PA)Minimum of 2 years of experience as an Advanced Practice Provider or equivalent clinical roleMinimum of 5 years nursing experience including home care or closely related serviceClinical research experience as a Sub-Invest...