NAMSA

Senior Field Clinical Research Associate

NAMSA

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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 overall 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

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.
Benefits
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial experiencemonitoring experiencedevice trial experiencestudy document managementquality control reviewdata managementliterature searchessite qualificationsite initiationadverse event tracking
Soft Skills
verbal communicationwritten communicationorganizational skillsindependent workmentoringliaisingproblem-solvingteam collaborationattention to detailtraining
Certifications
Society of Clinical Research Associates (SoCRA)Association of Clinical Research Professionals (ACRP)