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Clinical Research Associate Job in United States Recruiting by NAMSA

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Clinical Research Associate

🏢 NAMSA
📌 United States, United States, United States
💼 other general
⌚ 17 hours ago

🔖 Full Time

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Description

:• 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

Qualifications & Technical Competencies:

Principal Duties and Responsibilities

▪ Independently performs investigational site qualification, interim and site close-out monitoring visits in accordance with NAMSA Standard Operating Procedures. Completes and writes applicable visit report and follow-up letter. Independently performs site initiation visits including conducting site and study specific training in accordance with NAMSA Standard Operating Procedures. Writes site initiation visit report and follow-up letters. Responsible for collecting and completing associated documentation during visit.

▪ Addresses and closes (whenever possible) site issues/monitoring action items during onsite visits.
▪ Reviews clinical data for completeness, clarity and conflicts. Issues data queries as needed to resolve inconsistencies or obtain additional information during onsite visits.
▪ Reviews Investigator Site Files during onsite visits in accordance with NAMSA Standard Operating Procedure and study monitoring plan. Collects documents for internal site files as needed.
▪ Instructs and educates site personnel on requirements for CRF completion, source documentation, GCP, study protocol, study file management, device management, maintaining blinding, etc. during onsite visits.
▪ Performs clinical device or biologic inventory and accountability per NAMSA Standard Operating Procedure and study monitoring plan.
▪ Responsible for ensuring compliance with all monitoring plan requirements
▪ Responsible for ensuring accuracy, completeness, and timeliness of visit reports, confirmation/follow-up letters.
▪ Responsible for ensuring accuracy and quality of collected documents and timely submission of these documents into the trial master file.
▪ Communicates with investigators during site visits, and via follow-up letters to inform of any issues as well as good performance.
▪ Identifies data trends during onsite visits and effectively communicates trends to iCRA and Study Manager and site study personnel as appropriate.
▪ Communicates with iCRA (as applicable) on site specific items.
▪ Per Sponsor request, develops monitoring requirements presentation and attends Investigator Meeting.
▪ Travels as needed (typically between 30%-60%) to meet project milestones.
▪ Performs role of iCRA as needed.

Qualifications and Skills

▪ Fluency in English and local language, if different, required.
▪ Bachelor’s degree or equivalent experience in a related field, with a minimum 2 years of current monitoring (preferred) and relevant clinical trial experience.

Working Conditions:

• 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.

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