Research Regulatory Specialist

Posted Date 4 months ago(8/11/2022 9:32 AM)
Job ID
2022-16350
Location
US-NY-New York
Category
Research & Academia - All Openings
Emp Status
Regular Full-Time
Hours per Week
35
Shift
Days
Minimum Hourly Rate/Annual Salary
USD $80,000.00/Yr.
Maximum Hourly Rate/Annual Salary
USD $90,000.00/Yr.

Overview

How you move is why we’re here. ®
Now more than ever.

Get back to what you need and love to do.

The possibilities are endless...

 

Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize

 the abundant opportunities for growth and success.

 

If this describes you then let’s talk!

 

HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment.

Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise

 

Research Regulatory Specialist
Full-Time

The HSS Clinical Research Administration (CRA) provides centralized services to foster and ensure safe, compliant and scientifically valuable patient-oriented research. CRA provides support to facilitate all functions of clinical research from study design and conception through final contract, IRB approval, study execution, and closeout. The Research Regulatory Specialist will work closely with the Director of Clinical Research Operations and the Quality Assurance and Regulatory Affairs Team to provide administrative support of the scientific Clinical Review Panels (CRP), Clinical Research Contracts Administration and the Institutional Review Board (IRB).

Collaborators with a deep experience in clinical research development and regulations, and have a strong interest in facilitating and streamlining processes among various parties are invited to apply. Applicants should have outstanding organizational skills, excellent interpersonal skills, and a proven ability to outreach and collaborate.

            The Research Regulatory Specialist interfaces across multiple HSS offices including the scientific CRPs, Biostatistics and Data Cores, Contracts Administration, Legal Affairs, HSS IRB, Clinical Research Finance, and Clinical Departments to provide comprehensive support and facilitation of clinical research projects. In collaboration with members of CRA, Legal Affairs, Principal Investigators, and study teams, the Research Regulatory Specialist may also interact with external stakeholders such as Pharmaceutical, Biotechnology, Device Manufacturer, Clinical Research Organizations, external IRBs, and external agencies such as the United States Food and Drug Administration (FDA).

 

Job Responsibilities  

Scientific Clinical Review Panels

In partnership with the Clinical Department’s Scientific CRP Administrator, Chairpersons, HSS Research Leadership, and the Biostatistics and Bioinformatics Program, the Research Regulatory Specialist will help promote and develop processes that allow CRPs to provide departmental-related protocol development, evaluation and oversight.

  • Assist in the development of guidelines for CRP submissions, meetings, study review, feasibility, prioritizations, risk level, and other review criteria.
  • Provide appropriate guidance and instruction regarding relevant review policies, guidelines and criteria
  • Promote communication between investigators, statisticians, administrators to facilitate team science and collaboration for clinical and translational research
  • Promote communication among research administrators, department heads, investigators, human participants, and institutional officials to maintain a high level of awareness regarding the ethical conduct of research and to safeguard the rights and welfare of participants
  • Educate members of the HSS research community to establish and maintain a culture of compliance with Federal regulations and institutional policies relevant to the protection of human participants
  • Orient new staff on the CRP review process and use of the electronic Clinical Application Portal (eCAP)
  • Administrator for CRP that reviews high risk studies. Organize CRP scoring and discussion, conflict of interest, submission of revised critiques, and debriefing
  • Perform quality control check of reviewers’ critiques to ensure their completeness, accuracy, and adherence to the recorded scores. Suggest edits to clarify language and remove inflammatory comments
  • Determine and assign reviewers based on the subject matter expertise required from the project’s description and CRP guidelines
  • Manage all real and perceived conflict of interests of reviewers against the proposed project
  • Monitor submission timeline and quality of draft critiques, provide appropriate feedback to study teams
  • Ensure CRP records are maintained per federal regulations and that the records are accessible, upon request, to authorized federal officials

 

Contracts Administration

Working alongside Research Contracts Administration and Legal Affairs:

  • Assist with intake for contracts submitted to Clinical Research Administration
  • Troubleshoot and triage contracts incorrectly routed to ensure negotiation by the appropriate central office
  • Coordinate efforts, as directed, among HSS, clients, suppliers, external counsel, and/or consultants to facilitate timely execution of clinical research contracts
  • Oversee contract negotiation communications performed by Research Contracts Administration or external representatives on behalf of Research Contracts Administration; assess the status of contracts based on these communications, records and reports the progress of negotiations
  • Manage listserv communications ensuring escalated items are prioritized and resolved
  • Route agreements for signature with approval from Clinical Research Administration or Legal affairs; manages dissemination and filing of clinical research agreements.
  • Assist with Clinical Research Contracts Administration metrics reporting to ensure targets are aligned with established goals

 

Clinical Research Regulatory

  • Working alongside the Research Administration Quality Assurance and Regulatory Affairs team:
  • Assist Principal Investigators and study teams with their clinical research regulatory oversight
  • Assist in the review protocol logistics and feasibility
  • Assist with centralization of ClinicalTrials.gov services ensuring results are reported in a timely fashion
  • Assist in audits by reviewing and collecting regulatory documents as needed
  • Assist with IND and IDE submissions and annual reports, participate in pre-IND meetings as needed
  • Participate in HSS CRP and IRB meetings
  • Ensure that all appropriate regulations are followed throughout the course of a research project
  • Ensure that research protocols are approved by the Institutional Review Board and followed as written
  • Generate reports on the progress of assigned research projects

 

Qualifications Desired

  • Bachelor's degree required; Master’s degree preferred
  • Three to five years of research related experience in academic or healthcare setting
  • Regulatory and contracts administration experience
  • Solid understanding of regulatory requirements related to 21 CFR and medical device regulations
  • Solid understanding of regulatory application process
  • Capacity to communicate regulations to investigators and study teams
  • Ability to manage relationship with investigators, study teams, sponsors, and regulatory agencies when applicable
  • Detail oriented and proficient at reviewing and editing scientific and regulatory documents
  • Ability to independently interpret, analyze, and implement appropriate policies in a given situation
  • Ability to provide organizational and administrative support to research initiatives
  • Ability to communicate clearly and concisely, both orally and in writing
  • Ability to establish collaborative working relationships, manage multiple projects and deadlines
  • Ability to multi-task while maintaining rigorous attention to detail
  • Participate in special projects and task forces as needed
  • Performs other related duties as assigned

Qualifications

 

 

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