Senior Contract Specialist - Research Administration - Orlando FT

Senior Contract Specialist â“ Research Administration - Orlando

Location Address:  800 N. Magnolia Ave., Orlando, FL 32801

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

•  Full Time, Days

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. The Senior Contract Specialist actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

• Bachelorâ™s degree in legal studies, healthcare, business administration, finance, accounting, or research-related field OR paralegal certification

• Three (3) yearsâ™ experience in reviewing, writing, editing, and negotiating contracts

•  preferably in an academic or medical setting

• Experience in research or contract administration

• 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 (e.g. human subjects, animal, confidentiality, biohazard, export control, intellectual property, etc.)

• Proficient knowledge of related federal and state regulations, e.g. Food and Drug Administration (FDA), Department Health and Human Services (DHHS), Code of Federal Regulations (CFRs), Office of Management and Budget (OMB), as they relation to research administration

• Proficient knowledge of research compliance requirements (e.g. human subjects, animal, biohazard, export control, intellectual property, etc.)

• Excellent interpersonal skills and a collaborative style necessary for interaction across departments.

• Motivated, organized and able to function independently

• Advanced written and verbal communication skills with demonstrated proficiency for current spelling, grammar, tone, and syntax

• Proficient in MS Office Suite (Outlook, Word, Excel, Publisher, PowerPoint, etc), internet, and other research tools, word-processing and databases

• Over three (3) 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.

• 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 Administratorâ™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)

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

• In coordination with the Manager Sponsored programs, Clinical Trial Agreements & Contracts manages efforts and workflow to achieve department goals and objectives, such as decreased activation times.

• Creates, reviews, revises, and negotiates simple and complex research-related contracts, including amendments, consistent with relevant clinical trials study documents (e.g. protocol, informed consent, budget, manuals, etc.), institutional policies and procedures, and applicable federal, state, and local regulations.

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

• Follows, develops, and updates established processes pre and post-execution to ensure metrics and tracking, compliance, document harmonization, and timely execution of contracts.

• Consults with stakeholders and partners to solve simple and complex problems related to research studies and applying knowledge of applicable regulations, institutional policies and procedures, and logistics and programmatic requirements of conducting research.

• Facilitates the execution of clinical trial agreements and/or related requests.  Serves as a liaison with the Institutes, Research Operations and AdventHealth Legal department to ensure clinical trial and other agreements are processed timely. 

• Interacts directly with all levels of management and staff to provide useful information, guidance, and integrity to contract negotiation, execution, and compliance.

• Assists in developing, enhancing, and communicating policies and procedures in research administration.

• Manages and/or assists with special projects in research administration processes, as assigned.