Clinical Research Associate - Research Administration

Location US-NY-New York
Posted Date 3 months ago(11/3/2021 2:05 PM)
Job ID
2021-14926
Category
Administrative/Clerical Support - All Openings
Emp Status
Regular Full-Time
Hours per Week
35
Shift
Days

Overview

Position Title: Clinical Research Associate

 

The Clinical Research Administration (CRA) has established a centralized service center to provide Principal Investigators and administrative leaders within Service Lines with efficient and essential support for clinical research projects. As part of the centralized service center, the Clinical Research Associate is responsible for the administrative support of the scientific Clinical Review Panels (CRP), Clinical Research Contracts Administration, and Clinical Research Regulatory Administration.

 

The Clinical Research Associate interfaces across multiple HSS offices including the scientific CRPs, Institutional Review Board (IRB), Biostatistics and Data Cores, Legal Affairs, Contracts Administration, Clinical Research Finance, and Ancillary Departments to provide comprehensive support and facilitation of clinical research projects. In collaboration with Clinical Research Administration, Legal Affairs, Principal Investigators and/or research teams, the Clinical Research Associate may also interact with numerous Pharmaceutical, Biotechnology, Device Manufacturer and Clinical Research Organizations, external collaborative organizations, external IRBs, and external agencies such as the United States Food and Drug Administration (FDA).

 

Job Responsibilities  

Scientific Clinical Review Panels

  • Determine reviewer expertise required for the CRP based on project description and CRP guidelines
  • Assign reviewers based on subject matter expertise required by the CRP and meet the overall criteria outlined by the project
  • Assign project submission to reviewers and manage all real and perceived conflict of interests
  • Provide appropriate guidance and instruction to reviewers and study teams regarding relevant review policies, guidelines, and criteria; critiques preparation and submission
  • Monitor submission timeline and quality of draft critiques, provide appropriate feedback to study teams
  • Administrator CRP review meeting, CRP scoring and discussion, conflict of interest, submission of revised critiques, and CRP debriefing
  • Perform quality control check of reviewer critiques to ensure their completeness, accuracy, and adherence to the recorded scores editing to clear scientific language and removing inflammatory comments
  • Ensure CRP records are maintained per federal regulations and that the records are accessible, upon request, to authorized federal officials
  • 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 in order 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)

Clinical Research Regulatory

  • Work with Principal Investigators and study teams to assist in all aspects of clinical research regulatory oversight
  • Act as an institutional liaison for external IRBs
  • Assist in protocol submissions to external IRBs, draft, revise and review informed consents, and review protocol logistics
  • Act as an institutional liaison for Researchmatch.com registry and other recruitment tools

Assist with centralization of clinicaltrials.gov services, including 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 monthly 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
  • Ensure that workflow is controlled and meets Clinical Research Administration and study team needs
  • Generate reports on the progress of assigned research projects

Contracts Administration

  • Manages intake for contracts submitted to Clinical Research Administration
  • Troubleshoots and triages contracts incorrectly routed to ensure negotiation by the appropriate central office
  • Coordinates efforts, as directed, among HSS, HSS clients, suppliers, external counsel, and/or consultants to facilitate timely execution of clinical research contracts
  • Oversees contract negotiation communications performed by Clinical Research Contracts Administration or external representatives on behalf of Clinical Research Contracts Administration; assesses the current status of all contracts based on these communications, records and reports the progress of negotiations
  • Manages listserv communications and ensures escalated items are prioritized and resolved
  • Ensures the final Clinical Research Finance approved budget and payment terms (if applicable) are incorporated into the final agreement before routing for signature
  • Routes agreements for signature with approval from Clinical Research Administration or Legal Affairs; manages dissemination and filing of clinical research agreements.
  • Assists with Clinical Research Contracts Administration metrics reporting to ensure targets are aligned with established goals
  • Manages study team orientation of the Clinical Research Contracts Administration process

Qualifications

Minimum Qualifications

  • Bachelor's degree required; Master’s degree preferred
  • Two to four years of related experience in academic setting and fast-paced environment
  • 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 established and new 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

 

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