Medical Protocol Advisor

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 & Responsibilities

• Develop, draft, and compile policy or procedures documents for the program either independently or as part of a working group.
• 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 relevant guidelines.
• 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 applicable).
• 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 expertise.
• Contribute to the review of individual protocols presented at Scientific Review Committees, from a human subject protection perspective.
• 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 research.
• 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 privacy protections).
• 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 administration.
• 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 development.
• Experience advising senior-level team members.
• Experience working with HIV and/or TB studies, desirable.

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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.