For
more information about the following job announcement, contact Andi Hernandez, Beth Israel Deaconess Medical
Center in Boston, MA
at xxxxxx@bidmc.harvard.edu
Beth Israel Deaconess
Medical Center
Boston, MA 02215
Position
Title: Director, Human Subjects Protection Office
Department/Section:
Research & Academic Affairs/Human Subjects Protection Office
Reports
To (Position Title): Vice President, Research Operations
Grade:
TBD Job Code: TBD FLSA Status: Exempt
Date
Prepared: April 2007 HR Approval: ________
Position
Summary
Reporting directly to the
Vice President of Research Operations, this position provides administrative
and staff oversight for the Human Subjects Protection Office (HSPO). The HSPO
is responsible for implementing and maintaining programs across the Human
Subjects Protection System (i.e. IRB, Clinical Trials Office, Study Teams, Office
of Business Conduct, etc.). The programs developed will also support the
requirements for accreditation by the Association for Accreditation of Human Research
Protection Programs, Inc. (AAHRPP) and the Harvard-wide Clinical Translational
Science Award (CTSA). This includes, but is not limited to: monitoring and
supporting the Research Community’s efforts related to the BIDMC Data
Safety Monitoring Plan policy; implementing and monitoring compliance with the
CTPro patient registration database; overseeing the clinical research auditing
program; implementation and oversight of the clinical trials education program;
and participation on the Clinical Research Operations Committee.
Primary
Duties and Responsibilities
- Manages the initial application process for AAHRPP
accreditation, which includes planning/implementation of any HSPO programs
to meet AAHRPP requirements, primary responsibility for written materials
for the AAHRPP application, and coordination of written materials/program
planning from other Research & Academic Affairs (R&AA) divisions
(i.e. IRB, CTO, OBC, etc.) required for the AAHRPP submission.
- Oversees the database management of the CTPro Patient
Registration system. Manages the process for implementing this system
within the various clinical trial departments, monitoring the usage, and
automation of additional clinical trial data, as appropriate. Develops
procedures for quality control and issues related to missing data.
Actively work with the PIs and study teams to ensure proper use of the
system.
- Manages the BIDMC clinical trial audit program to: 1)
ensure clinical protocol compliance and safety based on applicable federal
and state laws, and BIDMC-established guidelines, policies, and
procedures; 2) detect and correct systems errors in BIDMC polices and
procedures that lead to non-compliance and risk to subjects; and 3) educate
investigators and study teams through critique and performance appraisal
to promote a greater awareness and understanding of policies, procedures
and objectives, and to increase efficiency and consistency in the clinical
trial process at BIDMC.
- Manages the Data Safety Monitoring Plan, which
includes providing a monitoring process after study activation and monitoring
throughout the conduct of the study. This includes support and
supervision of any required internal Data Safety Monitoring Boards.
Serves as a consultant to Investigators in assessing the risk level of
protocols in preparation for submission to the Scientific Review Committee
(SRC) and IRB.
- Develops a quality assurance program to audit
internal procedures related to the human subjects protection program.
- The Director will review data obtained from the data
safety monitoring and auditing functions and will have the authority to
recommend to the IRB to stop a protocol if, in his/her judgment, research
participants have been, are, or will be placed at risk for serious harm.
- Independently composes and edits complicated and
sensitive correspondence, reports and documents related to outcomes and
findings of HSPO programs.
- Prepares, analyzes and summarizes data
from all HSPO programs to provide statistics for the VP and the Clinical
Research Operations Committee.
- Supervises the Manager of Education and the
corresponding clinical trial education program for PIs and study teams
which include knowledge of applicable federal, state, and local
regulations, relevant professional standards, and BIDMC’s policies
and procedures regarding the protection of research participants. The
education program must also provide research participant outreach and
educational opportunities to participants, prospective participants and/or
their communities to enhance their understanding of research involving
human participants
- Develops written policies and operational procedures
for the HSPO.
- Regularly assesses programs and implements
improvements as required.
- Manages the hiring and training for HSPO staff;
perform annual performance reviews as well as any disciplinary action
necessary.
- Works with the Administrative Director for Research
& Academic Affairs in the budgeting process and on special projects.
Qualifications/Skills
& Knowledge Requirements:
- Bachelor’s degree (minimum), Graduate degree
preferred
- Five to ten years
experience in a clinical research environment
- Experience with
and strong knowledge of the regulations governing Institutional Review
Boards and human subject research. Experience at an AAHRPP accredited
organization preferred.
- Demonstrated managerial experience to effectively
manage large-scale, highly visible projects, present information in person
and in writing and leverage resources and motivate staff. Must be able to
discern between the need to lead certain initiatives and supporting others
in their desire to lead efforts.
- Demonstrated excellent verbal and written
communications skills and the ability to effectively compose, and present
complex information, recommendations and resolutions to all levels of
personnel including management, Investigators, and staff.
- Five to ten years experience supervising staff
- Must demonstrate courtesy and respect and protect
patient and employee confidentiality at all times.
Supervisory/Management Responsibility
Manage
a HSPO staff of six (6) FTE’s; one (1) Manager of Education; two (2)
Auditors (one full-time, one part-time); one (1) Junior Auditor; and two (2)
Administrative Assistants.
Anastacia
Feldman
Research Compliance Officer
Office of Business Conduct
Beth Israel Deaconess
Medical Center
109 Brookline
Avenue, Suite 300
Boston, MA 02215
Tel. 617-667-1873
Fax. 617-667-1896
xxxxxx@bidmc.harvard.edu