Human Subject Protection Specialist

Job Description

Job Description

Position - Human Subject Protection Specialist

Remote Flexibility: Hybrid; 2 days onsite in Bethesda, MD and 3 days remote.

Contract Term: Contract-to-Hire

• Contract rates:
• • Pay: Target roughly $30-35/hr based on the $60,000-$75,000 conversion range

Job Description

• Act as a Clinical Research Ethicist, providing expertise on the implementation of relevant Human Subjects Protection regulations in clinical research.
• Conduct regulatory and bioethical reviews of clinical trial protocols and related documents, including domestic and international sample and site-specific informed consent documents, for compliance with applicable regulations and policies.
• Carry out literature reviews of ethical codes, regulations, and guidance documents relevant to human subjects' protection in clinical research.
• Train, mentor, and/or supervise staff on application of regulations.
• Develop, review, and update informed consent templates, SOPs, and internal guidelines to promote high-quality work products.
• Develop and maintain quality control procedures to ensure appropriate work processes are followed and high-quality and timely work products are delivered appropriately to clients.
• Provide support for complex projects and client requests related to human subjects protection and clinical research.
• Assist in evaluating existing processes and workflows to identify opportunities for digitization, automation, use of AI, and process optimization to ensure compliance with human subjects protection regulations in clinical research, streamline efforts, and enhance quality.

Job Requirements

• Excellent writing, interpersonal skills, critical thinking skills, and attention to detail.
• Working knowledge of the Common Rule and other regulations/policies/guidances relevant to the protection of human subjects in clinical research.
• Experience in medical writing, IRB activities, clinical site coordination, and/or regulatory affairs is highly desirable.
• Experience in/demonstrated interest in bioethics or a clinical research environment is a plus.
• Proficient in Microsoft Office.
• Experience collaborating with IT or technical teams on digital transformation, workflow automation, AI, data analytics, or process-improvement initiatives is a plus.

Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.

Beacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.

Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.

Company Description

Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.\r\n\r\nBeacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.\r\n\r\nWhether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.