Note: The job is a remote job and is open to candidates in USA. NAMSA provides medical device development and clinical research solutions across the product development lifecycle. The Senior Clinical Research Associate manages clinical site monitoring, study documentation, regulatory compliance, site communications, and clinical trial operations, with field-based travel as required.

Responsibilities

• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines
• May 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 relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc
• Performs study-related training
• Manages the development and maintenance of study documents, processes and systems as assigned
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals
• Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance
• Attends internal and external meetings as required
• Provides all job-related progress reports and visit documentation as required
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc
• OUS: Prepares and coordinates submissions to regulatory authorities
• May perform other activities as assigned
• Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process
• Assists with the coordination of the site budget and contract negotiations as directed by the project lead(s)
• Assists in preparing sites for audits and in resolving audit action items
• Supports sites during audits remotely and/or onsite as needed
• Participates in meetings with prospective clients
• Supports training and mentoring of CRAs during remote and onsite visits
• Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents
• Assists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development
• Supports Core Laboratory management and may serve as the primary contact
• Supports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks
• Performs and summarizes literature searches
• Registers trials on Clinicaltrials.gov

Skills

• •    Fluency in English and local language, if different, required
• •    Higher education degree or equivalent education, training, and 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
• •    Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates
• •    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• •    While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus
• •    Extensive use of a computer keyboard
• •    Preferred 5 years clinical trial experience
• •    Preferred 3 years monitoring experience
• •    Preferred 1 year device trial experience
• •    Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required

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