Clinical Research Director - 991356
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Nova Southeastern University (NSU) was founded in 1964, and is a not-for-profit, independent university with a reputation for academic excellence and innovation. Nova Southeastern University offers competitive salaries, a comprehensive benefits package including tuition waiver, retirement plan, excellent medical and dental plans and much more. NSU cares about the health and welfare of its students, faculty, staff, and campus visitors and is a tobacco-free university.
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Primary Purpose:
Oversees all the clinical visit and associated data collection aspects of human subjects research conducted under the Office of Clinical Trials. Develops relationships with hospital partner(s), faculty, and community-based principle investigators.
Job Category: Exempt
Hiring Range:
Pay Basis: Annually
Subject to Grant Funding? No
Essential Job Functions:
1. Oversees Phase 1 through 4 drug studies, device studies, emergency and compassionate use.
2. Develops and implements sub-specialty-specific research strategic plans and clinical trial portfolios.
3. Supports NSU’s hospital partnership(s).
4. Assists with developing specific departmental goals, standards and objectives which directly support the strategic plan and vision of the organization, NSU Health, and the Office of Clinical Trials.
5. Develops and maintains relationships with external stake holders such as pharma companies, sponsors, and collaborators to ensure access to clinical trials and innovation projects and to develop strong research portfolios across all specialties.
6. Works with and educates principle investigators, research staff and sponsors to acquire and implement new clinical trials in the the clinical setting.
7. Implements and ensures all electronic medical record systems’ functionality is kept current to support clinical trials and participate in continuous process improvement initiatives.
8. Supervises Clinical Trial Management system implementation, training and continuous utlization by clinical research team.
9. Supervises all FDA and sponsor related monitoring visits and audits from clinical perspective.
10. Communicates with and educates physicians, faculty, research staff, students and new research hires regarding all aspects of best research clinical practices.
11. Completes special projects as assigned.
12. Performs other duties as assigned or required.
Job Requirements:
Required Knowledge, Skills, & Abilities: 1. Knowledge of Human Subjects Research Regulatory and Clinical Requirements
2. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
3. Applies sound judgment and analytical reasoning to evaluate complex information, identify issues, and develop effective, evidence-based solutions.
4. Demonstrates effective communication skills to lead and oversee teams, manage audits, and educate research personnel at all levels.
5. Demonstrates strong complex problem-solving skills by analyzing multifaceted issues, identifying root causes, and developing innovative, practical solutions to ensure effective research operations.
6. Exhibits decisive judgment and the ability to make sound decisions independently with minimal supervision.
7. Possesses superior writing skills with the ability to craft clear, accurate, and persuasive documents, reports, and correspondence that effectively convey complex information to diverse audiences.
8. Adaptable in dynamic environments, able to pivot quickly and take appropriate, effective action.
Required Certifications/Licensures:
Required Education: Bachelors with Clinical Degree as part of post secondary education
Major (if required:
Required Experience: 1. A minimum of ten (10) years clinical work experience.
2. Five (5) years in research personnel management.
Preferred Qualifications:
Certified Research Professional
Is this a safety sensitive position? No
Background Screening Required? Yes
Pre-Employment Conditions:
Sensitivity Disclaimer: Nova Southeastern University is in full compliance with the Americans with Disabilities Act (ADA) and does not discriminate with regard to applicants or employees with disabilities and will make reasonable accommodation when necessary.
NSU considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status or any other legally protected status.