Clinical Research Associate
ProTrials Research Inc.
Field Clinical Research Associate
NAMSA
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Works on assigned studies to ensure human subject protection, Good Clinical Practice (GCP), and applicable regulations are followed.
- Coordinates and manages clinical site monitoring responsibilities for assigned studies per contracts, SOPs, and regulatory guidelines.
- Conducts on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits as needed.
- Serves as primary point of contact for site questions related to study enrollment, conduct, and close-out; liaises with study team members.
- Communicates site performance, trends, deficiencies, and concerns to site investigators and project team via verbal and written communication.
- Supports study start-up activities, quality reviews of study documents, and distribution of site activation letters.
- Performs study-related training and manages development/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 and renewals.
- Tracks study site and overall study metrics including enrollment, deviations, adverse events, and trial master file maintenance.
- Attends internal and external meetings; provides progress reports and visit documentation.
- May support safety activities such as narrative writing and managing CEC/DSMB; OUS: prepares and coordinates submissions to regulatory authorities.
- May 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 2 years clinical trial experience.
- Preferred monitoring 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.
- Willingness/ability to travel (up to 80% for Field Clinical Research Associates).
- Ability to occasionally lift and/or move up to 25 pounds and meet physical/vision requirements.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial experiencemonitoring experiencestudy-related trainingstudy document managementsite monitoringsite qualificationsite initiationadverse event trackingtrial master file maintenancequality reviews
Soft skills
verbal communicationwritten communicationorganizational skillsindependent workliaisingproblem-solvingattention to detailteam collaborationreportingtime management
Certifications
Society of Clinical Research Associates (SoCRA)Association of Clinical Research Professionals (ACRP)
