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Clinical Advisor

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Bethesda, Maryland
Start date
Sep 30, 2022

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Discipline
Clinical, Clinical Research
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioCapital
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Job Details

We are currently searching for a Clinical 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 Bethesda, MD.

 

Duties & Responsibilities
  • Provide human subject protections related advice and guidance on protocols and associated documents on COVID-related studies, including ACTIV-2.
  • Participate in program 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 protocol.
  • Possess and maintain knowledge of pertinent human subject protections regulations including Office for Human Research Protections (OHRP), Food and Drug Administration (FDA) regulations, ICH guidelines, and any other applicable laws, regulations, policies, and guidance.
  • Advise the protocol team on complex issues involving human subject protections.
  • Participate in team calls, branch meetings and other meetings, as requested.
  • Contribute to and participate in inspection preparedness activities.
  • Maintain up-to-date knowledge of regulatory and policy changes, including new and existing guidance documents on human subject protections.
  • 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 program staff and stakeholders.
  • Advise the branch chief and the 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, and other program leadership, as requested.
Requirements
  • Master’s Degree or higher in a related field.
  • Minimum of five (5) years of relevant of experience years in the field of human subject protection and policy development.
  • Experience conveying regulatory and policy changes regarding human subject protection and offering extensive advisement to senior leadership, on applicable laws, regulations, and guidance.

 

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.

 

 

Company

Medical Science & Computing (MSC), a Dovel company, is 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. The Dovel Family of Companies combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management. 

MSC has long supported Federal health organizations like the National Institutes of Health (NIH) and applies deep understanding of missions, goals, and operations to discover and implement innovative approaches for streamlining and disseminating research efforts, enhancing knowledge sharing, and improving public health. 

Together, Dovel and MSC offer a diverse set of complex biomedical, scientific, and technology services, coupled with attentive and purpose-driven program management to serve mission critical organizations and drive meaningful change in the world.

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Find Us
Website
Location
11300 Rockville Pike Suite 1100
Rockville
MD
20852
United States
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