Manager - Research Regulatory Services Administration

Manager - Research Regulatory Services Administration
Orlando, FL

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

Work Hours/Shift
Full-Time, Days

The Manager - Research Regulatory Services Administration will be responsible for the following:

  • 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.
  • Manages Florence eRegulatory application including role assignments, access, and workflows.
  • Facilitates the review of research regulatory documents for sponsor monitors, and external auditors working with the site department.
  • Develops and maintains standardized processes for regulatory workflows across all regulatory staff.
  • Coordinates regulatory processes for AHRI led multi-site research.
  • Ensures 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.
  • Creates and facilitates 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.


Education and Experience Required:

  • Associate's degree in biological sciences or healthcare related field.
  • 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).
  • 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.


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.


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.


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.


Apply online at: http://link.adventhealth.com/tp/rj6_M62yt_e.K
 

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

Contact Information

AdventHealth

Lourdes

Daverio

800 N. Magnolia Ave.

Orlando, Florida 32801

407-776- 5260

Background Information

2-Year Degree

3

  • Hospital
  • Research Administrator/Manager

None

Target Job Information

  • Full Time