Medical Protocol Advisor
Company: Regional Recreation Corporation of Wood Buffalo
Posted on: February 25, 2021
Careers - MSC - Medical Protocol Advisor in Rockville, Maryland
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Welcome page Returning Candidate? Log back in! Medical Protocol
Advisor Job ID 2021-9717 # of Openings 1 Job Location(s)
US-MD-Rockville Posted Date 4 days ago (1/15/2021 8:30 PM) Category
Science, Research & Regulatory Overview We are currently searching
for a Medical Protocol Advisor to provide support to the National
Institutes of Health (NIH). This opportunity is a full-time
position with MSC, and it is on-site in Rockville, MD. Duties &
- Develop, draft, and compile policy or procedures documents for
the program either independently or as part of a working
- Provide leadership, editorial expertise, and consultative
support to the program through the creation of Clinical Research
policies and related procedures, as well as human subjects clinical
research policies, in compliance with all applicable US Federal
regulations and international guidelines, such as ICH, and other
- Provide advice to staff on the interpretation of human
subjects' protections regulations, protocol compliance in the area
of human subject protections, and the additional requirements under
45 CFR 46 Subparts B, C, and D as well as other applicable
regulations (21 CFR 50, etc) and guidelines (ICH and others as
- Serve as the subject matter expert, providing expertise on HIV,
associated comorbidities (such as TB), etc. needed to evaluate
human subject protection issues, and maintain such scientific
- Contribute to the review of individual protocols presented at
Scientific Review Committees, from a human subject protection
- Provide direct human subjects protections support to protocol
development teams, clinical operations offices, project specific
working groups and other program stakeholders in their oversight of
the implementation of program sponsored and/or funded clinical
- Provide advice to inform the departmental Branch Chief of
activities related to policies; perform project management, and
administrative tasks related to development and/or modification of
policies and procedures.
- Conduct in-depth research for development and/or modification
of clinical research policies in a variety of areas (for example,
clinical trial conduct and oversight, safety, research participant
- Review and edit existing policies and procedures per QMS
process and timelines.
- Provide NIH and program-wide benchmarking, policy research, and
analyses in support of policy development, management, and/or
- Serve as a Content Manager for the internal ProPEP policies and
procedures and external clinical research policy website.
- Develop policy briefings for the departmental Branch Chief, and
other program leadership. Requirements
- M.D. from an accredited university required.
- Minimum of years (5) years direct experience in clinical trial
management, preferably with planning and implementing clinical
research and protocols.
- Expertise in leading initiatives in support of clinical
portfolios and study research.
- Experience reviewing and evaluating reports relating to the
performance and safety of trials and adverse events.
- Experience with clinical program policy and procedural
- Experience advising senior-level team members.
- Experience working with HIV and/or TB studies, desirable.
LH-DD1 Company Description We are a trusted government partner that
blends deep domain expertise with advanced technologies to help our
customers solve complex problems that improve, protect, and save
lives. As a rapidly growing company, we combine entrepreneurial
spirit, customer focus, and an outcomes-based approach to support
agency missions in health IT, life sciences, public safety, and
grants management. The Dovel Family of Companies offers
employees--an opportunity to advance beyond a specific role or
contract, we--offer a path to develop an enriching career.--We
believe--in empowering a culture of innovation, customer success,
and employee growth. What you'll get---
- Time Off! Flexible schedules and company paid holidays allow
you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to
keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options
like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs,
we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care
Flexible Spending, HSA with company contributions, parking, and/or
transit commuter benefits.
- Support! Working parents and busy professionals - we've got you
covered with a supportive culture, confidential Employee Assistance
Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs,
company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and
have your voice heard. We are an Equal Opportunity Employer with a
commitment to diversity. All individuals, regardless of personal
characteristics, are encouraged to apply. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, gender, sexual orientation, gender identity,
disability, or veteran status. Options Apply for this job online
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Keywords: Regional Recreation Corporation of Wood Buffalo, Rockville , Medical Protocol Advisor, Healthcare , Rockville, Maryland
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