Senior Clinical Research Associate
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Clinical Research Associate supporting NAMSA’s medical-device clinical trials. Managing site monitoring, regulatory documentation, audits, study metrics, and clinical research operations.
Responsibilities:
- Work on assigned studies to ensure human subject protection, Good Clinical Practice (GCP), and applicable regulations are followed
- Coordinate and manage clinical site monitoring responsibilities in accordance with contractual agreements, SOPs, and regulatory guidelines
- Conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits
- Serve as primary point of contact for site questions about enrollment, conduct, and close-out issues
- Communicate site performance, trends, deficiencies, and concerns to site investigators and project teams
- Support study start-up activities, including study document tracking and quality review and site activation letters
- Perform study-related training
- Manage study documents, processes, systems, monitoring plans, templates, trackers, tools, and site-specific documents
- Ensure quality and completeness of central and site master files; track required documents, perform quality control reviews, and manage renewals
- Track site and overall study metrics, including enrollment, deviations, adverse events, and trial master file maintenance
- Attend internal and external meetings and provide progress reports and visit documentation
- Support safety activities, including narrative writing and managing the CEC/DSMB
- Prepare and coordinate submissions to regulatory authorities OUS
- Assess investigative site suitability and provide input to site selection
- Assist with site budgets and contract negotiations
- Assist sites with audits and resolution of audit action items; support audits remotely and onsite
- Participate in meetings with prospective clients
- Support training and mentoring of CRAs during remote and onsite visits
- Assist the Clinical Study Manager with clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development
- Support Core Laboratory management and serve as primary contact when assigned
- Support data management, including CRF development, validation rules, UAT, data review, trend identification, and reporting/analysis
- Perform and summarize literature searches
- Register trials on Clinicaltrials.gov
- Perform other activities as assigned
Requirements:
- Fluency in English and local language, if different, required
- Higher education degree or equivalent education, training, and experience
- Preferred 5 years clinical trial experience
- Preferred 3 years monitoring experience
- Preferred 1 year device trial experience
- Able to work independently once trained
- Good verbal and written communication skills
- Strong organizational skills
- Basic computer proficiency
- Understanding of clinical research processes and regulations
- Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
- Extensive use of a computer keyboard
- Ability to occasionally lift and/or move up to 25 pounds
- Ability to meet the stated physical demands, with reasonable accommodations where applicable
Benefits:
- Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Equal employment opportunity
- Pre-employment background and drug screen processes aligned to local, state and federal laws
Similar Jobs
Clinical Study Manager
Clinical Study Manager leading medical-device clinical trials at NAMSA, a global MedTech development solutions provider. Managing sites, study deliverables, compliance, and cross-functional teams.
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence organisation. Ensuring protocol compliance, data integrity, and patient safety.
Senior Clinical Data Manager
Senior Clinical Data Manager leading end-to-end clinical data management for Indero, a global dermatology and rheumatology CRO. Building EDC databases, ensuring data quality, and supporting database lock.
Director, Clinical Research Billing
Director overseeing clinical research billing compliance, revenue cycle, and staff operations at Stanford Health Care. Managing coverage analysis, audits, invoicing, and clinical trial billing workflows.
Senior Clinical Research Specialist
Senior Clinical Research Specialist managing investigator-sponsored medical-device studies for Medtronic. Overseeing clinical compliance, contracts, budgets, logistics, and global research stakeholders.
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organisation. Ensuring protocol compliance, data integrity, patient safety, and high-quality study data.
Senior Clinical Research Specialist
Senior Clinical Research Specialist managing investigator-sponsored research for Medtronic’s surgical medical-device business. Overseeing clinical operations, compliance, contracting, payments, and device logistics.
Clinical Data Manager
Clinical Data Manager leading clinical trial data management and data quality for ICON, a global clinical research organisation. Owning study data from start-up through database lock and close-out.
Clinical Research Associate II
Clinical Research Associate II monitoring diagnostic clinical studies for Karius, a genomic infectious-disease diagnostics company. Managing investigative sites, data verification, compliance, and monitoring visits.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and research organization. Ensuring protocol compliance, data integrity, site performance, and regulatory standards.
Head of Clinical Research
Head of Clinical Research leading grants, publications, and research governance for CSD’s autism and developmental-services network. Advancing evidence-based ABA, telehealth, and technology-enabled care.
Clinical Research Associate II
Clinical Research Associate II advancing AbbVie’s innovative medicines through clinical trial site management. Monitoring sites, ensuring compliance, data integrity, recruitment, and patient safety.
Senior Biostatistician, Clinical Trial Experience Required
Senior Biostatistician leading clinical-trial design, programming, and statistical reporting for CTI, a global full-service clinical research CRO. Overseeing SDTM/ADaM analyses, regulatory submissions, and project delivery.
Clinical Research Associate, U.S. Expert Network
Clinical Research Associate joining Alcedis, a Germany-based clinical research organization expanding in the United States. Supporting oncology and Alzheimer’s clinical trials through flexible, project-based monitoring assignments.
Senior Clinical Research Associate
Senior Clinical Research Associate advancing AbbVie’s innovative medicines through site monitoring and clinical trial execution. Partnering with investigators and study teams to ensure compliance, patient safety, data integrity, and recruitment success.
Senior Manager, Clinical Trial Management
Senior clinical trial manager overseeing pharmaceutical and device studies for Precision Medicine Group. Leading feasibility, monitoring, compliance, recruitment, vendors, and clinical teams remotely in the United States.
Senior Biostatistician
Senior Biostatistician leading observational studies using real-world clinico-genomic cancer data for AACR Project GENIE. Designing analyses, programming in R, and translating findings into publications.
Principal Biostatistician
Principal Biostatistician leading statistical strategy, analyses, and regulatory delivery for Fortrea’s global clinical-trial programs. Mentoring statisticians and advising multidisciplinary teams across complex CRO studies.
Clinical Research Manager
Clinical Research Manager overseeing ophthalmology trials for TFS HealthScience, a global contract research organization. Coordinating CRAs, sites, sponsors, monitoring quality, and study delivery across Poland, Spain, and Italy.
Clinical Research Lead
Site Engagement Liaison building clinical trial site relationships for ICON, a global healthcare intelligence and clinical research organisation. Supporting study compliance, engagement strategies, and site performance.