Senior Clinical Research Associate

Job not on LinkedIn

🕒 October 6

🇺🇸 United States – Remote

💵 $125k - $135k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Clinilabs

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Clinilabs is a global, full-service Contract Research Organization (CRO) specializing in the development of central nervous system (CNS) drugs, devices, and technology. The company provides comprehensive services to pharmaceutical, biotechnology, and medtech organizations, supporting their projects from first-in-human to Phase 3 clinical trials. Clinilabs is dedicated to addressing the significant unmet needs in CNS drug development, focusing on neurological, mental health, and substance use disorders.

📋 Description

• Review study protocols, Investigator Brochures, Clinical Monitoring Plans, and study-related documents • Conduct site qualification, initiation, routine monitoring, and close-out visits • Assess investigator qualifications, site capabilities, patient populations, and facility resources • Serve as the primary contact and resource for assigned investigative sites • Monitor source documentation, case report forms (CRFs), and electronic data capture (EDC) systems • Perform source data verification (SDV) and source data review (SDR) • Verify informed consent documentation, subject eligibility, protocol compliance, and patient safety • Identify, document, track, and follow up on protocol deviations, CAPAs, and site retraining activities • Generate, review, and resolve data queries with investigative sites, data management, and study team members • Review adverse event documentation, investigational product accountability records, and other study-related documentation • Monitor regulatory documentation and essential study records • Maintain study tracking tools, monitoring records, and regulatory documentation • Ensure investigative sites maintain adequate study supplies and resources • Communicate with site personnel regarding recruitment, enrollment, retention, and study progress • Identify site performance issues, compliance concerns, and study risks and communicate findings to the Project Manager and study team • Prepare monitoring visit reports, follow-up letters, and other required study documentation • Provide updates on study status, site performance, enrollment, and study progress • Participate in investigator, sponsor, and study team meetings and training sessions • Assist with development and review of CRFs, study manuals, tracking tools, and regulatory materials • Support training and mentoring of CRAs and investigative site personnel • Assist with study start-up activities, site feasibility assessments, site selection, and collection of essential documents • Contribute to departmental initiatives, quality improvement, process enhancements, and clinical operations best practices • Maintain awareness of industry trends, regulatory developments, and advancements in clinical research • Perform other assigned duties, including trip report review

🎯 Requirements

• Bachelor's degree in Life Sciences, Nursing, or a related field; equivalent experience may be considered • Minimum of five (5) years of clinical monitoring experience, including direct monitoring experience in CNS clinical trials, within a pharmaceutical, biotechnology, contract research organization (CRO), or academic research environment • Demonstrated knowledge of the clinical drug development process, clinical trial conduct, regulatory requirements, and clinical monitoring practices • Strong knowledge of ICH-GCP guidelines and applicable FDA and international regulatory requirements • Experience with electronic data capture (EDC) systems, CTMS and eTMF systems and clinical trial documentation processes • Excellent verbal and written communication, organizational, time management, and interpersonal skills • Strong attention to detail and the ability to effectively prioritize and manage multiple responsibilities • Ability to work independently while collaborating effectively within a cross-functional team environment • Strong analytical, problem-solving, and critical-thinking skills • Certified Clinical Research Associate (CCRA) certification preferred but not required • Ability to travel approximately 60% to 80%, including overnight travel, as required to support assigned clinical studies and attend company training meetings