Clinical Research Operations Director - 991351 *Internal to Department Only*

We are excited that you are considering joining Nova Southeastern University!

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.

We appreciate your support in making NSU the preeminent place to live, work, study and grow. Thank you for your interest in a career with Nova Southeastern University.

Primary Purpose:

Oversees of all the operational, regulatory and onboarding aspects of human subjects research conducted at NSU. Develops relationships with federal, state and industry sponsors and entrepreneurs to ensure a robust pipeline of clinical trials.

Job Category: Exempt

Hiring Range: 

Pay Basis:  Annually

Subject to Grant Funding? No  

Essential Job Functions: 

1. Develops and implements sub-specialty-specific research strategic plans and clinical trial portfolios.

2. Develops and continues oversight of process to onboard new clinical trials to include all necessary parties (legal contracts, finance Medicare coverage analysis and budget, Clinical trial management system build out, physicians, research staff, research pharmacy, regulatory IRB start up, build of study into electronic medical system)

3. Develops and oversees interventional trial feasibility process (scientific, legal contract, budget, staffing logistics, operational logistics, patient population, FDA involvement)


4. Supports NSU’s hospital partnerships.

5. Assists with development of 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.

6. Develops and maintains relationships with external stakeholders 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.

7. Implements and operationalizes study protocols, operational plans and electronic systems ensuring that all standard operating procedures are carried out in accordance with all federal, state and local SOPs and ethical guidelines.


8. Implements and ensures all regulatory systems are kept current to support clinical trials and participates in continuous process improvement initiatives.

9. Supervises Research legal contracts process flow.

10. Supervises all FDA and sponsor related monitoring visits and audits.

11. Communicates with and educates physicians, faculty, research staff, students and new research hires regarding all aspects of best research regulatory practices.

12. Completes special projects as assigned.

13. Performs other duties as assigned or required.

Job Requirements: 

Required Knowledge, Skills, & Abilities: KNOWLEDGE:
1. Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
2. English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
3. Medicine - Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventative health-care measures.
4. Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
5. Expert knowledge of Human Subjects Research Regulatory Requirements.


SKILLS:
1. Management of Personnel Resources - Basic skills in motivating, developing, and directing people as they work, identifying the best people for the job.
2. Active Listening - Advanced skills in giving full attention to what other people are saying, taking time to under the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
3. Coordination - Advanced skills in adjusting actions in relation to others' actions.
4. Reading Comprehension - Advanced understanding of written sentences and paragraphs in work-related documents.
5. Writing - Advanced skills in communicating effectively in writing as appropriate for the needs of the audience.
6. Speaking - Advanced skills in talking to others to convey information effectively.
7. Critical Thinking - Advanced skills in using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
8. Judgment and Decision Making - Advanced skills in considering the relative costs and benefits of potential actions to choose the appropriate one.
9. Monitoring - Advanced skills in monitoring / assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
10. Time Management - Advanced skills in managing one's own time and the time of others.


ABILITIES:
1. Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
2. Oral Expression - The ability to communicate information and ideas in speaking so others will understand.
3. Written Comprehension - The ability to read and understand information and ideas in writing so others will understand.
4. Written Expression - The ability to communicate information and ideas in writing so others will understand.
5. Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.
6. Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (including finding a relationship among seemingly unrelated events).
7. Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.


Physical Requirements:
1. Near Vision - Must be able to see details at close range (within a few feet of the observer).
2. Speech Recognition - Must be able to identify and understand the speech of another person.
3. Speech Clarity - Must be able to speak clearly so others can understand you.
4. Travel - Must be able to travel on a daily and/or overnight basis.
5. May be required to work nights or weekends.
6. May be exposed to short, intermittent, and/or prolonged periods of sitting and/or standing in performance of job duties.
7. May be required to accomplish job duties using various types of equipment/supplies, to include but not limited to pens, pencils, and computer keyboards.

Required Certifications/Licensures: 

Required Education: Masters Degree

Major (if required: 

Required Experience: A minimum of ten (10) years of progressive work experience in research personnel management, and research-related legal contracts.

Preferred Qualifications: 

Certified Research Professional.

Is this a safety sensitive position? No  

Background Screening Required?  No  

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 is an Equal Opportunity Employer and 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.