Senior Contract Specialist FT Days - AdventHealth Orlando

Location Address:  800 N MAGNOLIA AVE, Orlando, 32803

Top Reasons to work at AdventHealth Orlando

• Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando
• serves as the major tertiary facility for much of the Southeast, the Caribbean and South America
• AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country
• We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year

Work Hours/Shift:

•  Full Time, Days

You Will Be Responsible For: 

GENERAL SUMMARY:

The Senior Contract Specialist will play a vital role in support of research under the auspices of AdventHealth. The Senior Contract Specialist exercises objective and independent judgement in interpreting regulations and contract language, negotiating terms and conditions, managing contract compliance, and in making recommendations to departments and leadership The Senior Contract Specialist is knowledgeable in the area of clinical trial agreement contract negotiation, terms and conditions. The Senior Contract Specialist will be responsible for the review, negotiation, tracking, finalization and administrative management of contracts and agreements to support the mission of AdventHealth Research Institute. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.  Adheres to AdventHealth Corporate Compliance Plan and to all rules and regulations of all applicable local, state and federal agencies and accrediting bodies.

PRINCIPAL DUTIES AND JOB RESPONSIBILITIES:

· Prepares memoranda, contracts, and/or documents related to research functions, including, but not limited to, clinical trial agreements and related documents (e.g. protocol, informed consent, budget, manuals, etc.), research agreements, operating agreements and license agreements.

· Reviews and negotiates research contracts, clinical trial agreements and related documents with outside corporate sponsors (e.g., pharmaceutical companies, medical device companies, etc). 

· Exercises independent judgement to provide interpretation of contract terms, federal, state, and local laws, and institutional policies and procedures internally and externally to resolve issues and to ensure compliance.

· Manages efforts and workflow to achieve department goals and objectives, including  decreased clinical trial activation times

· Develops and maintains strategic relationships with other AdventHealth Office of Research Administration offices including AdventHealth Research Departments/Institutes, and other internal stakeholders.

· Orients, trains, and mentors’ new staff as well as contract specialists in areas related to contract drafting and negotiation.

· Develops policies, procedures, governance materials, contracts, forms, memos and analysis documents.

· Adheres to Federal, State and local regulations (including HIPAA) as they pertain to assigned tasks. 

· Performs a wide range of assigned duties in support of total Department efficiency.

KNOWLEDGE AND SKILLS REQUIRED:

· Proficient knowledge and understanding of clinical trial agreements and other grant and contract funding mechanisms, including related policies and procedures, and contract management.

· Proficient knowledge and understanding of research related clinical trial and other related contract terms and compliance requirements (e.g. human subjects, animal, confidentiality, biohazard, export control, intellectual property, etc.)

· Knowledge of laws and regulations in the areas of clinical research or intellectual property

· Ability to use discretion when discussing research/personnel/patient related issues that are confidential in nature. 

· Responsive to ever-changing matrix of AHRI needs and acts accordingly. 

· Self-motivator, quick thinker. 

· High level of attention to detail.

· Strong customer service skills; well organized and communicates well; customer oriented; works independently or in teams, as situation requires.

· Ability to process and understand materials related to regulations, laws and policies

KNOWLEDGE AND SKILLS PREFERRED:

· Knowledge of AdventHealth policies and procedures related to research administration

· Knowledge of Florida laws/statutes

· Knowledge of HIPAA

EDUCATION AND EXPERIENCE REQUIRED:

· Bachelor’s degree in legal studies, healthcare, business administration, finance, accounting, or research-related field OR paralegal certification

· Five (5) years’ experience in reviewing, writing, editing, and negotiating clinical trial agreements preferably in an academic or hospital setting

· Experience in research or contract administration.

EDUCATION AND EXPERIENCE PREFERRED:

•           Seven (7) years of reviewing, writing, editing, and negotiating contracts preferably in an academic or medical setting

· Experience in grant and/or clinical trial agreement administration and management in a research or medical setting

LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:

· N/A

LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:

· Certification by a professional research organization such as Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators (SRA), Research Administrator’s Certification Council (RACC), or Health Care Compliance Association (HCCA)

· Certification by a paralegal professional organization such as The National Federation of Paralegal Associations (NFPA), The National Association of Legal Assistants (NALA), or The Association for Legal Professionals (NALS)

· Bar membership