ACE Partners · 16 hours ago
Clinical Research Associate
United States
Full-time
Remote
Mid, Senior Level
$70K/yr - $105K/yr
5+ years expACE Partners is seeking a Clinical Research Associate to conduct on-site and remote monitoring throughout the study lifecycle. The role involves ensuring protocol compliance, maintaining strong relationships with site investigators, and supporting various aspects of clinical research documentation and operations.
Staffing & Recruiting
Hiring Manager
Danielle Lea
Responsibilities
Conduct on-site and remote monitoring across the study lifecycle (qualification, initiation, interim, close-out)
Ensure subject eligibility, informed consent, protocol compliance, SDV, and timely query resolution
Track/report enrollment, deviations, data quality trends, and site performance; identify and escalate risks with mitigation plans
Serve as primary site contact, maintaining strong relationships with investigators/coordinators
Maintain inspection-ready documentation and support TMF/eTMF upkeep; manage investigational device accountability (as applicable)
Support IRB/EC submissions (amendments, continuing review/annual reports, correspondence) and complete visit reports/follow-up within timelines
Support feasibility/site selection, study timelines, and operational consistency; help develop study tools (monitoring plans, training, guides, checklists)
Coordinate with CROs and vendors (e.g., labs, imaging) and contribute to ongoing data review, quality initiatives, and audit/inspection readiness
Qualification
Required
Bachelor's degree and 5+ years clinical research experience; medical device experience preferred
Knowledge of GCP, ISO 14155, and FDA/ICH requirements
Proven monitoring and clinical data review experience (accuracy, completeness, compliance)
Strong communication, documentation, and organizational skills; able to manage priorities independently
Proficient with EDC/CTMS/eTMF systems
Preferred
Experience with cardiovascular/vascular/interventional or complex device trials
Device accountability and/or imaging endpoint experience
Experience working with CROs and multi-site, multi-region studies
Familiarity with risk-based monitoring and inspection-readiness best practices
Benefits
10% bonus
Company
ACE Partners
We have two specialist brands: ACE Partners - Medical Device Utilizing our expertise to provide recruitment solutions to cutting-edge companies in MedTech across the Globe looking to grow from the very beginning, through human, clinical trials, FDA and through to commercialization.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Joe Pridgeon
Founder & Managing Director
Company data provided by crunchbase