Clinical Research Scientist I (Temporary Position)

his temporary assignment focuses on collaborating with internal teams and external partners to help ensure high-quality, compliant, and meaningful research. Responsibilities span the study lifecycle, from concept development and protocol drafting through study closeout, including assisting with scientific planning, operational coordination, basic data review, and clear communication of results under senior team guidance. Support the scientific design of clinical studies under the guidance of a senior scientist/clinical lead, helping define objectives, endpoints, inclusion/exclusion criteria, visit schedules, and study methodology. Draft and maintain clinical study documents (protocols, amendments, informed consent forms, CRFs/source templates, manuals, and other study materials) in alignment with applicable guidelines (e.g., ICH-GCP) and internal SOPs. Partner with clinical research coordinators and/or clinical operations to translate protocols into site-ready tools, support participant flow planning, reinforce protocol adherence, and promote data quality. Collaborate with biostatistics to support development of analysis plans, sample size rationale (as applicable), randomization approaches, and data interpretation under supervision. Work cross-functionally with R D, Regulatory, Legal, and Marketing to ensure study plans and documentation meet scientific and business needs. Assist with external site and vendor interactions, including feasibility support, site start-up documentation, and ongoing communications as assigned. Track and support day-to-day study execution activities (e.g., enrollment/status tracking, protocol deviation logging, query follow-up, safety documentation routing, timeline updates); escalate risks/issues to the study lead. Support budget and timeline tracking, including purchase order/invoice reconciliation support and vendor performance tracking with oversight from the study lead. Review and summarize clinical data outputs and literature; contribute to study reports, abstracts, posters, manuscripts, and internal/external presentations. Ensure compliance with protocols, SOPs, ethical standards, and regulatory requirements by maintaining accurate documentation, audit readiness, and timely study file updates. Qualifications Education: PhD is preferred in a relevant life science, health science, public health, nutrition, or related field. Master's degree (MS/MPH) is accepted in a related discipline with appropriate clinical research experience and/or demonstrated ability to support clinical study execution and scientific writing. Experience: Typically, 0-2 years of experience in clinical research/clinical operations/scientific affairs (internships, co-ops, academic research coordination, or industry experience count). Foundational understanding (coursework or experience) of clinical study design, GCP/ICH, informed consent, and basic regulatory/ethics concepts. Basic familiarity with clinical data concepts and biostatistics fundamentals (e.g., endpoints, variability, sample size concepts). Strong written and verbal communication skills; ability to produce clear, accurate scientific documentation with feedback. Proficiency with common productivity tools (Microsoft Office/Google Workspace). Key Competencies Scientific writing: Able to draft and revise technical documents with attention to clarity, consistency, and version control. Detail orientation & quality mindset: Accurate documentation, strong follow-through, and comfort working within SOPs. Project coordination: Able to manage tasks, meet deadlines, and communicate progress/risks to the study lead. Collaboration: Works well with cross-functional partners and supports external communication professionally. Learning agility: Eager to develop skills in protocol development, study operations, and data interpretation; receptive to coaching and feedback. Integrity & professionalism: Maintains confidentiality and ethical standards in all study activities. Travel Requirements Minimal travel required. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.