Senior Clinical Research Associate

. Independently build and maintain successful working relationships with internal partners and site staff (e.g., Principal Investigators, Study Coordinators) .

Posted 5/21/2026full-timeRemote • Rhode Island • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Independently build and maintain successful working relationships with internal partners and site staff (e.g., Principal Investigators, Study Coordinators)
Acts as the primary liaison between BD and the investigational site
Perform all types of monitoring visits (i.e., on-site, virtual/remote, in-house) including Pre-Study (Qualification), Site Initiation, Interim, and Close-Out, according to plan
Conducts source document verification per plan
Routinely performs site document reviews to ensure compliance with applicable regulations and standards (e.g., GCP/ISO, IRB/EC policies and procedures
Site interactions involve prioritization of subject safety including appropriately administered informed consent
Review/report AE/SAEs and protocol deviations per industry and BD standards
Maintain audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters
Maintain all project supporting systems, e.g. CTMS, EDC, eTMF, etc
Produce proficient and timely documentation of monitoring activities/visits (e.g., timely and complete trip reports, contact records, etc. within company-specified quality standards)
Collaborate with the studies cross-functional team members and actively participate in meetings
Assist in development and delivery of site-facing presentation materials for Investigator Meetings, Initiation visits, etc.
Make sure site staff are adequately trained in all project-related requirements and tasks
Support audit activities, as appropriate
Ensure site(s) maintains an acceptable inventory of clinical supplies and associated documentation

Requirements

What you’ll need

Bachelor’s Degree or higher in a healthcare or science related field AND 2+ years of relevant clinical research experience is required
OR - Associate’s Degree or higher in a healthcare or science related field AND 3+ years of relevant clinical research experience is required
Good Clinical Practices (GCP) certification from an accredited program is required
Medical device experience is preferred
Fluent knowledge of spoken and written English language, including medical terminology
Superior written and verbal communication skills
Proficiency in presentation preparation and delivery
Technical savviness with an ability to understand the impact technology has on increasing effectiveness and performance
Previous experience with EDC, CTMS and eTMF systems required
Understanding of clinical study management processes and systems, including monitoring, investigational product handling, data management, etc.
Understanding of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPAA
Ability to work in and promote team cohesiveness in a virtual/remote environment
Exhibit flexible organizational change approaches with a growth mindset
Demonstrated ability to prioritize multiple tasks with challenging timelines and results
Ability to master understanding of the disease state and product(s) under investigation.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible working hours
Paid time off
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical research experiencesource document verificationmonitoring visitssite document reviewsaudit-ready regulatory filespresentation preparationdata managementinvestigational product handlingclinical study management processesmedical terminology

Soft Skills

written communicationverbal communicationteam cohesivenessorganizational skillsflexibilityprioritizationgrowth mindsetcollaborationtraining abilitiestechnical savviness

Certifications

Good Clinical Practices (GCP) certification