Research Contract Specialist II – Research Administration – AdventHealth Orlando
Location Address: 800 N. Magnolia Ave., Orlando, FL 32801
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.
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)
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
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
At AdventHealth, Extending the Healing Ministry of Christ is our mission. It calls us to be His hands and feet in helping people feel whole. Our story is one of hope — one that strives to heal and restore the body, mind and spirit. Our more than 80,000 skilled and compassionate caregivers in hospitals, physician practices, outpatient clinics, urgent care centers, skilled nursing facilities, home health agencies and hospice centers are committed to providing individualized, wholistic care.