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Sitero

WebsiteLinkedInAll Job Openings

201 - 500 employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

☁️ SaaS

Healthcare Insurance • Pharmaceuticals • SaaS

Sitero is a next-generation clinical trial solutions provider that accelerates clinical trials, ensures compliance and safety, and enables innovation through advanced technology and world-class services. They offer a wide range of clinical services, including site support and activation, data management, biostatistics, and drug safety. Sitero specializes in eClinical technology, providing end-to-end, technology-enabled services such as electronic data capture, randomization and trial supply management, clinical trial management systems, electronic consent solutions, and payment systems. Their services also include IRB ethical review, biosafety consulting, and pharmacovigilance agreements, ensuring comprehensive support for clinical research organizations.

📋 Description

• 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. • 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.

🎯 Requirements

• Advanced degree or equivalent experience in science, medicine, research ethics, regulatory affairs, biostatistics, veterinary medicine, biosafety, or related field (requirements vary by committee). • 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.