Clinilabs — орталық жүйке жүйесіне арналған емдеу әдістерін дамытуға бағытталған жаһандық келісімшарттық зерттеу ұйымы. Компания фармацевтикалық, биотехнологиялық және медициналық технологиялар саласындағы компанияларға адамға алғаш рет жүргізілетін зерттеулерден бастап 3-кезеңдегі клиникалық сынақтарға дейінгі клиникалық әзірлеу қызметтерін ұсынады. Ол неврологиялық аурулар, психикалық денсаулық және заттарды қолдану бұзылыстары бағыттарында жұмыс істеп, командаларға орталық жүйке жүйесіне арналған дәрі-дәрмектерді, құрылғыларды және технологияларды әзірлеудегі шешімі толық табылмаған күрделі мәселелерді шешуге көмектеседі.
Senior Clinical Research Associate, CNS Trials - Clinilabs (Remote, United States)
Clinilabs is seeking a Senior Clinical Research Associate to oversee CNS trial sites across the United States. The role focuses on GCP compliance, data integrity, site performance, and study execution, with substantial travel.
Америка Құрама Штаттары125 000 $ – 135 000 $ / жыл
ҚашықтанТолық жұмыс күніАға маманҚажетті Тіл: ағылшын тіліКлиникалық зерттеулерСипаттама
- Evaluate study protocols, Investigator Brochures, Clinical Monitoring Plans, and related trial documentation
- Complete site qualification, initiation, routine monitoring, and close-out visits
- Evaluate investigator credentials, site capabilities, patient populations, and facility resources
- Act as the principal contact and support resource for assigned investigative sites
- Oversee source records, case report forms (CRFs), and electronic data capture (EDC) platforms
- Conduct source data verification (SDV) and source data review (SDR)
- Confirm informed consent, participant eligibility, protocol adherence, and patient safety requirements
- Track, document, and follow up on protocol deviations, CAPAs, and site retraining actions
- Create, assess, and resolve data queries with sites, data management, and study team partners
- Review adverse event records, investigational product accountability, and other trial documentation
- Oversee regulatory files and essential study records
- Keep study trackers, monitoring documentation, and regulatory records current
- Confirm sites have sufficient study supplies and operational resources
- Coordinate with site staff on recruitment, enrollment, retention, and study performance
- Escalate site performance problems, compliance issues, and study risks to the Project Manager and study team
- Draft monitoring visit reports, follow-up correspondence, and other required study records
- Report on study status, site performance, enrollment, and overall progress
- Attend investigator, sponsor, and study team meetings and training programs
- Contribute to the development and review of CRFs, study manuals, tracking tools, and regulatory materials
- Help train and mentor CRAs and investigative site staff
- Support study start-up, feasibility reviews, site selection, and essential document collection
- Contribute to departmental programs, quality initiatives, process improvements, and clinical operations practices
- Stay informed about industry developments, regulatory changes, and advances in clinical research
- Handle additional assigned responsibilities, including trip report review
Талаптар
- Bachelor’s degree in life sciences, nursing, or a related discipline; equivalent professional experience may also qualify
- At least five years of clinical monitoring experience, including hands-on CNS trial monitoring in a pharmaceutical, biotechnology, CRO, or academic research setting
- Working knowledge of clinical drug development, trial operations, regulatory obligations, and monitoring methodology
- Thorough understanding of ICH-GCP and applicable FDA and international regulations
- Experience using EDC, CTMS, and eTMF platforms and managing clinical trial records
- Highly effective written and verbal communication, organization, time management, and relationship-building skills
- Meticulous attention to detail with the ability to prioritize and manage competing responsibilities
- Capacity to work autonomously while partnering effectively with cross-functional teams
- Strong analytical reasoning, problem-solving, and critical-thinking abilities
- CCRA certification is preferred but not mandatory
- Willingness to travel approximately 60% to 80%, including overnight trips, for assigned studies and company training meetings