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 appropria