Job Description

Senior Clinical Research Associate Key Responsibilities: Assist with site start-up activities (e.g. oversight of CRO start-up activities, accountable for essential document package review, site initiation slide deck, vendor training, participate in remote/or on-site initiation visits) and contribute to feasibility, as required. Collaborate with Internal Project Management to assist the CRO with review and negotiation of site and vendor budgets/contracts. Contribute to the development and review of study(s), patient and site facing documents (e.g. protocols, ICFs and study plans). Oversee the CROs monitoring activities (e.g. visit schedules, monitoring visit reviews, monitoring plan etc.). May conduct appropriate co-monitoring with CRO CRA, ensuring compliance with protocol and regulatory requirements. Provide additional clinical monitoring training to support CRO personnel, as needed. Attend CRO monitoring meetings. May include assigned monitoring responsibilities for sites. Review and oversee site KPIs, protocol deviations and metrics to identify trends and maintain data quality. Escalate site level risks or non-compliance, and in collaboration with Quality Assurance, review Site Corrective and Action Plans (SCAPAs), Corrective and Action Plans (CAPAs) and Site Audits with the CRO. Support the clinical and regulatory affairs in managing progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment and other tasks as assigned. Proactively review electronic data capture (EDC) and other monitoring tools for completion and to identify issues and generate queries. Identify and monitor risks and decisions at the study level and implementation of mitigation strategies. Identify potential operational challenges, and in collaboration with senior team members, provide guidance and solutions to ensure study execution remains on track. Responsible for the oversight of assigned vendors. Collaborate with internal teams (e.g. Clinical affairs, regulatory Affairs, project management, Medical affairs, CMC, etc.) to ensure seamless trial execution and provide regular study updates to the appropriate internal stakeholders. May be accountable for reviewing site or vendor invoicing and financial management in accordance with the clinical trial agreement / scope of work. Support TMF activities as required (e.g. review of TMF index, document provision, etc.). Support onboarding and mentoring of new department members. Required Education, Experience, Skills: At least 4+ years of relevant clinical operations experience and a BS or BA (Life Sciences or Health Sciences.) Prefer previous work experience in a CRO with monitoring and auditing experience. Independent on-site monitoring experience and training Excellent attention to detail, verbal, written, interpersonal and presentation skills are required Must be familiar with routine medical/scientific terminology; Proficiency with MS Office required, Smart Sheet proficiency desirable Knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials is required Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision Highly productive, engaged and accountable Team-player- desire to work in a fast-moving, dynamic environment This is a full-time position (40 hours/week), hybrid position. 20-50% during some portions of the studies. Salary range: Commensurate with experience Our Benefits: We are proud to offer health benefits, .

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