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Orlando, Florida AdventHealth Orlando

Description

Research Contract Specialist II - Research Administration - AdventHealth Orlando

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

Work Hours/Shift:

  • Full Time, Days

You Will Be Responsible For:

The Contract Specialist II will play a vital role in support of research under the auspices of AdventHealth. The Contract Specialist II is knowledgeable in the area of clinical trial agreement contract negotiation, terms and conditions. The 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 Contract Specialist II interprets regulations and contract language, negotiating terms and conditions, managing aspects of contract compliance, and in making recommendations to departments and leadership. Adheres to AdventHealth Corporate Compliance Plan and to all rules and regulations of all applicable local, state and federal agencies and accrediting bodies. The Research Contract Specialist II actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

Qualifications

What You Will Need:

EDUCATION AND EXPERIENCE REQUIRED:

  • Bachelor's degree in legal studies, healthcare, business administration, finance, accounting, or research-related field OR paralegal certification
  • Three (3)years' experience in 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.

EDUCATION AND EXPERIENCE PREFERRED:

  • Five(5) years of experience in 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 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

KNOWLEDGE AND SKILLS REQUIRED:

  • Proficient understanding of clinical trial agreements and other grant and contract funding mechanisms, including related policies and procedures, and contract management.
  • Understanding of research related clinical trial and other related contract terms (e.g. human subjects, animal, confidentiality, biohazard, export control, intellectual property, etc.)
  • Understanding of research compliance requirements (e.g. human subjects, animal, 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 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 understanding of research related clinical trial and other related contract terms (e.g. human subjects, animal, confidentiality, biohazard, export control, intellectual property, etc.)
  • Proficient understanding of research compliance requirements (e.g. human subjects, animal, biohazard, export control, intellectual property, etc.)
  • Knowledge of Florida laws/statutes
  • Knowledge of HIPAA

Job Summary:

  • 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.
  • 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 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.
  • Assists in developing, enhancing, and communicating policies and procedures in research administration.
  • Performs a wide range of assigned duties in support of total Department efficiency


This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.