Special Associate Compliance Officer - Human Subjects Research
Company: Nuvance Health
Location: Danbury
Posted on: May 12, 2022
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Job Description:
Nuvance Health has a network of convenient hospital and
outpatient locations — Danbury Hospital, New Milford Hospital,
Norwalk Hospital, and Sharon Hospital in Connecticut, and Northern
Dutchess Hospital, Putnam Hospital Center, and Vassar Brothers
Medical Center in New York — plus multiple primary and specialty
care physician practices locations, including The Heart Center, a
leading provider of cardiology care, and two urgent care offices.
Non-acute care is offered through various affiliates, including the
Thompson House for rehabilitation and skilled nursing services, and
the Home Care organizations.*Summary: **Purpose: * The Special
Associate Compliance Officer ("SACO") - Human Subjects Research and
Academic Affairs role will support compliance primarily with
respect to all research conducted at or supported by Nuvance Health
and all medical education activities within Nuvance Health. The
role will also support hospital compliance at a regional hospital.
The role is necessary to ensure: (i) integrity and compliance with
regulatory requirements and internal policies and procedures as
they relate to clinical and non-clinical research and academic
affairs activities (e.g., Graduate and Undergraduate Medical
Education); and (ii) the ongoing development, implementation, and
continuous improvement of effective human subjects research
compliance program aimed at preventing, detecting, and responding
appropriately to clinical and non-clinical research and academic
compliance-related risks.Responsibilities:The SACO shall be
responsible for, among other compliance-related functions, the
following:1. Manage compliance matters and provideday-to-day
compliance support and oversight in assigned areas of
responsibility. For example (i) implementation and monitoring of
the eight (8) elements of the Nuvance Health Corporate Compliance
Program; (ii) developing and conducting compliance training and
education initiatives; (iii) conducting internal investigations;
(iv) performing auditing and monitoring activities; (v) performing
risk identification and assessment activities; (vi) writing
compliance policies and procedures; and (vii) documenting,
monitoring, and responding to compliance reports, issues,
incidents, complaints, queries, and requests for guidance.2.Support
the implementation of applicable laws, regulations, guidelines,
policies, and procedures with respect to the operations of a
compliance program covering the conduct of human subjects research
and other scientific research related activities throughout Nuvance
Health in the following specific areas and topics: (i) Office for
Human Research Protections regulatory compliance ("OHRP"); (ii)
Institutional Review Board ("IRB") compliance; (iii) IRB
Authorization Agreement Standards & Monitoring; (iv) human subjects
research protections program compliance; (v) research compliance
and vulnerable subjects' protections; (vi) U.S. Food and Drug
Administration ("FDA") compliance; (vii) clinical trials
compliance; (viii) biosafety and recombinant DNA; (ix) radiation
safety; (x) genetic research including predisposition genetic
testing; (xi) internal investigations (research-related reports);
(xii) human subjects privacy and certificates of confidentiality;
(xiii) research billing; (xiv) financial conflicts of interest in
the research context; (xv) research grants compliance; (xvi)
biological agents and toxins; (xvii) research integrity and
research misconduct; (xviii) invention reporting; and (ix) export
controls.3. Support the implementation of applicable laws,
regulations, guidelines, policies, and procedures with respect to
the operations of a compliance program covering medical education
throughout Nuvance Health in the following specific areas: (i)
Accreditation Council for Graduate Medical Education requirements;
(ii) Medical Teaching Rule compliance; and (iii) academic or
student misconduct.4. Write or support the writing and/or review of
reports and communications for submission to regulatory agencies
(e.g., U.S. Department of Health & Human Services ("HHS"), FDA),
Industries (e.g., pharmaceutical and medical devices), federal
sponsors (e.g., National Institutes of Health, National Cancer
Institute, Department of Defense, or other federal agencies that
have adopted the Common Rule), and/or cooperative groups (e.g.,
Eastern Cooperative Oncology Group, NRG Oncology).5. Lead and/or
conduct complex investigations from initiation to completion and
demonstrate critical thinking and analytical skills. For example,
layout investigatory scope and plan for the execution of
investigation, apply the correct regulatory standards, spot gaps in
study records, apply proper logic to analyses, synthesize evidence
from multiple sources, and draw evidence-based inferences.6. Write
or assist the SCO with writing memoranda, developing PowerPoint
presentations, and interim and final investigative reports for
presentation to executives.7. Support Nuvance Health's standards
concerning the dissemination of scientific communications to ensure
compliance with the International Committee of Medical Journal
Editors (ICJME) standards,the CARE Guidelines for Case Reports, and
Nuvance Health's policy regarding proprietary information and data
derived through Nuvance Health-funded or supported research and
development.8. Support the SCO by working with key stakeholders to
conduct periodic reviews of policies and procedures associated with
medical education and the conduct of clinical and non-clinical
research to ensure continued compliance with applicable legal and
regulatory requirements and other applicable standards.9. Develop
or support the development of training materials and conduct
training of Nuvance Health Workforce Members.10. Support the
Executive Compliance Committee - Subcommittee on Human Subjects
Research ("ECC-HSR"). For example, prepare meeting agenda, take
minutes at meetings and perform operational or administrative tasks
to support the operations of the ECC-HSR Subcommittee.11. Develop
reporting on key compliance indicators, benchmarks, scorecards, and
dashboards related to research compliance and integrity.12. Develop
controls that foster an environment that promotes the responsible
conduct of research in compliance with standards set forth by the
Office of Research Integrity ("ORI").13. Work with a
cross-functional team (e.g., Marketing, Legal, Risk Management) to
support review of research-related press releases and other
externally-facing materials prior to dissemination.14. Assist the
SCO with preparing written memoranda, PowerPoint presentations,
dashboards, and other compliance metrics regarding Nuvance Health's
human subjects research, academic activities, and hospital
compliance program.15. Perform other compliance-related tasks as
directed by the SCO or other supervising compliance officer.16.
Maintain and model Nuvance Health values.17. Demonstrate regular,
reliable, and predictable attendance.18. Perform other duties as
required.Leadership Competencies: -Influencing skills -*The SACO
must: * (i) effectively communicate a culture of compliance,
ethics, professionalism, and zero tolerance for retaliatory
conduct; (ii) engage the Nuvance Health workforce, business
affiliates, and agents in a collaborative manner to facilitate the
development of internal controls, encourage the reporting of
compliance issues and concerns, (iii) assist the SCO with
developing Nuvance Health-wide training and education initiatives;
and (iii) display independence and an ability to lead others when
conducting job functions. -Managing complexity -The latitude of
decision-making with regard to projects assigned to the SACO will
range from a fair amount to a considerable amount depending on the
task at hand and the corresponding input and consultation required
by the SCO. The SACO will have considerable control over results,
which will be reviewed by the SCO. -Relationship-building through
integrity and trust -the SACO shall carry out his/her
responsibilities and functions in a manner that:--Builds trust and
confidence throughout the Corporate Compliance Office and Nuvance
Health;--Exemplifies the highest level of integrity, independence,
competence, and diligence in carrying out his/her
responsibilities;--Maintains open lines of communication with
fellow Corporate Compliance Office staff members, as well as
Nuvance Health workforce members, business affiliates, and
agents;--Demonstrates the ability to work in a collaborative manner
with fellow compliance team members and Nuvance Health
leadership.Functional/Technical Skills Requirements: -Health Care
Expertise* Through a combination of prior transferable work
experience, professional development activities, and education, the
SACO must be able to fully satisfy the following
requirements:--Possess a significant level of knowledge and
understanding of compliance program legal requirements and best
practices;--Possess knowledge of federal and state regulations
concerning human subjects research (e.g., regulations from HHS,
FDA, ORI, Good Clinical Practice (ICH-GCP E6-R2), and related
compliance program best practices; and--Possess a substantial level
of knowledge and understanding of how to appropriately conduct and
document internal investigations.Strategic/Analytical
Capability-The SACO shall have the following key
skills:--Experience conducting clinical research investigations,
including interviewing fact witnesses and investigatory subjects
and reviewing regulatory binders and source documents;--Ability to
independently assess regulatory and other reporting requirements
and support operational partners in preparing applicable reports to
parties (e.g., FDA, OHRP, ORI, states, industry sponsors,
cooperatives, grantors).--Excellent written and verbal
communication skills, analytical and critical thinking skills,
attention to detail, and project management skills.Information
Technology - The SACO shall have advanced computer skills including
a substantial understanding of and ability to use: Microsoft
PowerPoint, Excel, and Word.*Education and Experience: *A
Bachelor's Degree with at least four (4) years of job-related
experience or a Master's Degree with at least three (3) years of
job-related experience is required. A Bachelor's, Master's, or
Doctorate Degree in healthcare compliance, clinical trial
management, health sciences, public health or health services
administration, public administration, human resources management,
business administration, organizational effectiveness, or
management is a plus.License, Registration, or Certification
Requirements:The successful candidate shall hold the following
certifications and/or licenses within twelve (12) months of
appointment:Certification in Healthcare Research Compliance
("CHRC") from the Compliance Certification Board or Certification
as a clinical research professional from the Association of
Clinical Research Professionals ("ACRP-CP").*Location: * Summit-100
Reserve Rd*Work Type: * Full-Time*Standard Hours: * 40.00*FTE: *
1.000000*Work Schedule: * Day 8*Work Shift: * Monday through Friday
(hybrid remote)*Org Unit: * 239*Department: * Corporate
Compliance*Exempt: * Yes*Grade: * L2*Working conditions:
**Essential: ** Little or no manual skills/motor coord & finger
dexterity* Sedentary/light effort. May exert up to 10 lbs. force*
Generally pleasant working conditions.* Little or no potential for
occupational riskNHTA1Job Type: Full-time
Keywords: Nuvance Health, Danbury , Special Associate Compliance Officer - Human Subjects Research, Other , Danbury, Connecticut
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