Manager Research Regulatory Services Administration
Location: Orlando, Florida
Internal Number: 21013572
Manager Research Regulatory Services - Research Administration - AdventHealth 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
You Will Be Responsible For:
The Manager – Research Regulatory & IND is knowledgeable of all Federal regulations, International and accreditation standards, and AdventHealth Research Institute (AHRI) and Institutional Review Board (IRB) policies and procedures governing biomedical and clinical research. The Research Regulatory Manager will manage the Research Regulatory team who handles all of the IRB and regulatory submissions and processes for all of AdventHealth Research Institute (AHRI) research activities. The Research Regulatory Manager will guide the Research Regulatory team working towards the standardization and streamlining of research regulatory start-up, submission, maintenance, and close-out work flows and processes with a goal of efficiency and compliance. Acts as a liaison and facilitate regular and effective communication between the regulatory staff, the AHRI Orlando IRB, external central IRBs, the Office of Sponsored Programs (OSP), participating cooperative groups, consortiums, sub-contract sties, Investigators, Research Nurses, Data Managers, and pharmaceutical monitors. Actively contribute to providing outstanding customer service, accepts responsibility for maintaining relationships that are equally respectful to all.
What You Will Need:
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
Certification (upon hire or within first year) through any professional research organization such as the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine & Research (PRIM&R).
EDUCATION AND EXPERIENCE REQUIRED:
Bachelor’s degree in related field, including: Healthcare, Science, Administration, Nursing, or other related biological sciences, healthcare, or research field.
At least three years’ experience in research regulatory field, working with U.S. Federal research regulations, ICH GCP guidelines, and IRBs in a clinical research setting.
Demonstrated leadership such as participating in interdepartmental committees or leading a group/team or special projects successfully.
EDUCATION AND EXPERIENCE PREFERRED:
Bachelor’s degree in biological sciences, healthcare, administration, or research related field.
At least five years of experience in research regulatory field
One to three years management experience.
Public speaking/training experience.
Supervision of the Research Regulatory Services Team.
research staff and participating in inter-departmental discussions relevant to clinical research.
KNOWLEDGE AND SKILLS REQUIRED:
In-depth knowledge of U.S. Federal research regulations and governing agencies and bodies, including, but not limited to, The Common Rule, Food and Drug Administration (FDA) regulations for research with investigational drugs, devices, and biologics, International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP), Association for the Accreditation of Human Research Protection Programs (AAHRPP), as well as applicable State laws.
Expertise in the submission process of research regulatory documents to an IRB and to Federal agencies (i.e., FDA) as required, including experience working with Central IRBs.
Motivated, proactive and able to function with minimal direction, prioritizing tasks and workflow for the Research Regulatory team.
Leadership skills demonstrated by the ability to lead a group to complete an assigned task or goal.
Strong multi-tasking skills with the ability to adjust priorities as needed.
Ability to be flexible in a fast-paced environment and respond to the changing needs and rules of clinical research regulatory requirements, standards, and guidelines.
Strong written and verbal communication skills.
Excellent organizational and electronic filing skills.
Proficient in Microsoft Office applications and internet skills.
KNOWLEDGE AND SKILLS PREFERRED:
Knowledge of AHRI Orlando IRB policies and procedures.
Experience working with cancer cooperative groups.
Experience with National Institutes of Health (NIH) and National Cancer Institute (NCI) requirements, and/or Oncology clinical research.
Experience with Investigator Initiated studies.
Experience with Emergency and Treatment Investigational New Drug (IND) applications to the FDA.
Proficient in Florence eRegulatory application.
Expertise in IRBNet electronic IRB application.
Knowledge of medical terminology.
Performs a variety of supervisory duties related to the management, performance, evaluations, development and workflow of the Research Regulatory team.
Manages the work assignments, priorities and productivity of the research regulatory staff.
Manage Florence eRegulatory application including role assignments, access, and workflows.
Facilitate the review of research regulatory documents for sponsor monitors, and external auditors working with the site department.
Develop and maintain standardized processes for regulatory workflows across all regulatory staff.
Coordinate regulatory processes for AHRI led multi-site research.
Ensure effective communication between AHRI coordinating site and all participating study teams for all multi-site studies and Investigator Initiated Studies (IIS) with more than one location or site.
Provides and/or ensures regulatory support for AHRI investigators conducting AHRI sponsored FDA regulated research, (Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and maintenance.
Create and facilitate streamlined process for emergency IND submissions (FDA and IRB processes).
Oversees orientation and training of new research regulatory staff.
Provides study activation support for AHRI IIS, assisting with site initiation activities.
Provides quality assurance and quality control oversight of the regulatory process ensuring each project is audit ready at all times.
Works closely with the ORI Director and Research Compliance Manager to ensure proper research compliance is maintained and all documents are submitted to the IRB in accordance with State, and Federal regulations.
Assists ORI Director and Research Compliance Manager with the development of AHRI Standard Operating Procedures (SOPs)
Contributes to providing efficient customer service by maintaining open communication with all research staff and participating in inter-departmental discussions relevant to clinical research.
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