Clinical Advisor (ProPEP
Company: Regional Recreation Corporation of Wood Buffalo
Posted on: February 22, 2021
Clinical Advisor (ProPEP) in Rockville, Maryland - Careers at
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back in! Clinical Advisor (ProPEP) Job Locations US-MD-Rockville ID
2021-1135 Category Science & Engineering Type Full Time Overview
ORAU has a contingent job opportunity for a Clinical Advisor (
ProPEP ) in support of the overall functions of the Office for
Policy in Clinical Research Operations, Division of AIDS (DAIDS),
National Institute of Allergy and Infectious Diseases (NIAID) for
the ACTIV2 clinical trial, located in Rockville, MD. The positions
are contingent on a ward of an upcoming contract with NIAID
Professional, Scientific and Technical Support Services. Salary for
positions will be determined based on education and experience.
Relocation support is not available for this position. ORAU has
been providing--scientific and technical talent staffing
solutions--and designing, managing, and evaluating--jobs and
internships--for more than 70 years. ORAU assists in connecting the
best and most diverse group of students, recent graduates, faculty
and professionals with world-class fellowships,--internships and
job opportunities, whether in national laboratories, research
institutions, federal government offices or private sector R&D
- Provide human subject protections related advice and guidance
on protocols and associated documents.
- Participate in PSRC and CSRC and full regulatory reviews as
applicable, and provide advice on human subject protections-related
aspects of the protocol under review.
- Provide advice on human subject protections-related aspects of
the protocol and related documents throughout the lifecycle of the
- Possess and maintain knowledge of pertinent human subject
protections regulations including Office for Human Research
Protections (OHRP), Food and Drug Administration (FDA) regulations,
and ICH guidelines.
- Advise the protocol team on complex issues involving human
- Participate in team calls, branch meetings and other meetings,
- Contribute to and participate in inspection preparedness
- Maintain up-to-date knowledge of regulatory and policy changes,
including new and existing guidance documents on human subject
- Interpret human subject protection regulations and policies in
a clear and consistent manner.
- Communicate new information related to human subject
protections and policies to Branch Chief, other DAIDS staff and
- Advise the branch chief and the OPCRO Director of any
significant/relevant changes to the requirements that relate to
human subject protections.
- Provide advice to inform the departmental Branch Chief of
activities related to assigned tasks; perform project management,
and related administrative tasks.
- Provide status updates and recommendations to the departmental
Branch Chief, such as, on resolution of issues, etc.
- Develop briefings for the protocol team, departmental Branch
Chief, OPCRO leadership and/or other DAIDS' leadership, as
- All support positions required a minimum of a BS degree; some
require a MS, MD, or Ph.D.
- At least 5 years of relevant of experience years in the field
of human subject protection and policy development.
- The education, skills and relevant years of experience required
for each support position are consistent with those identified as
the minimum requirements for the labor categories specified in the
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get started. At ORAU, we are committed to a diverse workforce and
ensuring equal employment opportunity for all persons. ORAU is
committed to eliminating profiling, promoting diversity and to
providing equal employment opportunity for all. Employment
practices will be made without discrimination against any employee
or applicant for employment because of race, color, age, religion,
sex, sexual orientation, gender identity, national origin, mental
or physical disability, protected veteran's status or genetic
information. Requests must comply with federal travel expenditure
guidelines. EEO is the Law poster --(PDF) Application FAQs Software
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Keywords: Regional Recreation Corporation of Wood Buffalo, Rockville , Clinical Advisor (ProPEP, Healthcare , Rockville, Maryland
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