社区IBC成员(奥古斯塔)
Community IBC Member (Augusta)
Sitero 是生命科学行业临床服务和软件解决方案领域的新兴领导者。我们拥有在多种治疗领域丰富的经验和专业知识,专注于通过技术实现的创新解决方案,使我们的客户能够专注于其核心优势。从早期阶段研究到III期临床试验,我们经验丰富的团队提供高关注度的服务和技术,确保临床研究社区中所有利益相关者的安全,重点在于伦理、合规和创新。
职位名称:研究合规委员会成员
工作地点:远程
部门:交付
主要职责和责任:
研究合规委员会成员是负责审查研究方案、监控法规合规性并确保研究参与者、动物、数据完整性和生物安全标准保护的专家。该角色支持多个机构审查和监督委员会的伦理、科学和法规监督。成员需运用法规知识、专业判断和独立性,以确保符合机构和联邦的合规标准。
核心职责:
- 审查研究提交内容是否符合法规、伦理和机构合规要求。
- 准备并积极参与安排的会议。
- 评估研究方案中的风险、收益和防护措施。
- 识别不合规情况、方案偏差或安全问题。
- 保守敏感研究信息的机密性。
- 对研究的批准、修改、暂停或终止提出建议。
- 按照机构政策记录审查和决定。
- 完成必要的培训和利益冲突披露。
机构生物安全委员会(IBC):
- 审查涉及重组或合成核酸、生物危害和传染性病原体的研究。
- 评估隔离级别、实验室安全程序和人员保护措施。
- 确保遵守生物安全法规和机构生物安全手册。
- 评估事件报告和纠正措施。
- 为危险生物工作推荐风险缓解策略。
教育要求:
· 科学、医学、研究伦理、法规事务、生物统计学、兽医学、生物安全或相关领域的高级学位或同等经验(具体要求因委员会而异)。
查看英文原文
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: Research Compliance Committee Member
Location: Remote
Function: Delivery
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The Research Compliance Committee Member serves as a subject-matter contributor responsible for reviewing research protocols, monitoring regulatory compliance, and ensuring protection of research participants, animals, data integrity, and biosafety standards. The role supports ethical, scientific, and regulatory oversight across multiple institutional review and monitoring committees. Members are expected to apply regulatory knowledge, professional judgment, and independence to ensure institutional and federal compliance standards are met.
Core Responsibilities:
- Review research submissions for regulatory, ethical, and institutional compliance.
- Prepare for and actively participate in scheduled meetings.
- Evaluate risks, benefits, and safeguards within research protocols.
- Identify non-compliance, protocol deviations, or safety concerns.
- Maintain confidentiality of sensitive research information.
- Provide recommendations for approval, modification, suspension, or termination of studies.
- Document reviews and determinations in accordance with institutional policies.
- Complete required training and conflict-of-interest disclosures.
Institutional Biosafety Committee (IBC):
- Review research involving recombinants or synthetic nucleic acids, biohazards, and infectious agents.
- Assess containment levels, laboratory safety procedures, and personnel protections.
- Ensure adherence to biosafety regulations and institutional biosafety manuals.
- Evaluate incident reports and corrective actions.
- Recommend risk mitigation strategies for hazardous biological work.
EDUCATION REQUIRED:
· Advanced degree or equivalent experience in science, medicine, research ethics, regulatory affairs, biostatistics, veterinary medicine, biosafety, or related field (requirements vary by committee).
EXPERIENCE REQUIRED:
- Demonstrated knowledge of research regulations and ethical principles.
- Prior service on compliance or oversight committees.
- Regulatory or clinical research experience.
- Training in human subjects protection, animal welfare, biosafety, or data monitoring
COMPENSATION & BENEFITS:
This is a contract role paying and hourly rate, depending on experience.
EMPLOYMENT TYPE:
Contractor
COMMITMENTS:
- Attendance at scheduled meetings (frequency varies by committee).
- Independent review time prior to meetings.
- Participation in ad hoc reviews or urgent matters when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
Salary: $110-125 per meetingOriginally posted on Himalayas