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DSMB Member, Physician

Job not on LinkedIn

🔥 0 minutes ago

🐊 Florida – Remote

infoinfo

💵 $2k / day

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

Where this job comes from

Posted on Sitero's careers page, not through a job board

First seen by Remote Rocketship 0 minutes ago

Logo of Sitero

Sitero

201 - 500 employees

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

Healthcare • Consulting • Healthcare Insurance

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

• 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 • Remain current with applicable regulations, guidance, and best practices • Review interim study data for participant safety and data integrity • Assess adverse events, trends, and stopping rules • Recommend continuation, modification, or termination of trials • Evaluate statistical analyses and safety monitoring plans • Ensure confidentiality of interim data and deliberations • Attend scheduled meetings, complete independent review time before meetings, and participate in ad hoc reviews or urgent matters when needed

🎯 Requirements

• Advanced degree or equivalent experience in science, medicine, research ethics, regulatory affairs, biostatistics, veterinary medicine, biosafety, or related field (requirements vary by committee) • Physician with demonstrated experience in early-phase biologic product safety oversight, preferably involving first-in-human clinical trials • Experience evaluating safety data for allogeneic, cell-based, tissue-derived, extracellular vesicle (EV), or other advanced biologic therapies • Strong expertise in assessing immunogenicity, hypersensitivity reactions, and systemic safety signals during early clinical development • Prior experience serving on Data and Safety Monitoring Boards (DSMBs), Safety Review Committees (SRCs), or similar independent oversight committees • Experience chairing Phase I clinical trial safety reviews and leading multidisciplinary safety discussions • Background in immunology, clinical immunology, or a related specialty with expertise in immune-mediated adverse events • Ability to interpret emerging safety data from small patient cohorts and make risk-based recommendations regarding study continuation and participant safety • Familiarity with regulatory considerations for first-in-human Investigational New Drug (IND) studies and advanced biologic products • Complete required training and conflict-of-interest disclosures • Maintain independence from study sponsors and investigators

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