Clinical Protocol Advisor

Location
Rockville, MD, US
Posted
Apr 11, 2021
Ref
2021-9776
Hotbed
BioCapital
Required Education
Other
Position Type
Full time
Overview

Medical Science & Computing (MSC) is currently searching for a Clinical 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 & Responsibilities

  • Provide human subject protections related advice and guidance on protocols and associated documents.
  • Participate in 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, and ICH guidelines.
  • 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 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 program leadership, as requested.


Requirements

• Master of Science in Nursing or a related field.
• Minimum five (5) years of experience in the field of human subject protection and policy development required.
• Experience participating in regulatory reviews and advising on regulatory guidelines and policy changes.
• Project management experience is highly desired.
• Excellent oral and written communications skills required.

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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.