Senior Clinical Research Associate

PROMETRIKA, LLC

. Ensure the rights and well-being of human subjects are protected and trial data are accurate, complete, and verifiable .

Posted 10/24/2026full-timeCambridge • Massachusetts • United StatesSenior💰 $145,000 - $165,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Clinical Research Associate (CRA) roles, with a strong focus on compliance with ICH, GCP, and regulatory standards. Proficient in managing clinical trial activities, including site monitoring, training, and documentation, while ensuring the protection of human subjects and data integrity.

Highest-signal resume keywords

Clinical Research Associate ExperienceOncology ExperienceGCP ComplianceSite MonitoringTraining Junior CRAs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementQuality Risk AssessmentData-Query ResolutionProtocol-Deviation ReportingSAE Case-ManagementStudy TrackingEnrollment TrackingCAPA TrackingDocument DevelopmentMonitoring Plan Development

Soft Skills

Excellent Written CommunicationExcellent Oral CommunicationOrganizational SkillsAttention to DetailEffective Team Collaboration

Tools & Technologies

Medidata Rave EDCRCM eTMFCTMSMedical ImagingTSDVPatient CloudMicrosoft Office

Certifications & Qualifications

Bachelor’s Degree in Scientific DisciplineClinical Training/Licensure (e.g., RN, LPN)

Industry Keywords

ICHGCPSOPsClinical TrialsHuman Subjects ProtectionStudy MonitoringVendor ManagementRisk ManagementInvestigator MeetingsBusiness Development

Tech Stack

Tools & technologies

CloudGoogle Cloud Platform

About the role

Key responsibilities & impact

Ensure the rights and well-being of human subjects are protected and trial data are accurate, complete, and verifiable
Oversee overall trial conduct at assigned study sites and ensure compliance with SOPs, ICH, GCP, regulations, company goals, and budgets
Oversee and track study monitoring activities, including CRA selection and management, trip report review, and monitoring/co-monitoring visits
Contribute to protocols, consent forms, CRFs, study manuals, monitoring plans, training materials, and other key study documents
Participate in vendor selection, qualification, and management
Conduct quality risk assessments, develop KRIs, and support risk management activities
Manage sites, including training, data-query resolution, monitoring findings, enrollment tracking, informed-consent compliance, IP accountability, supplies, and protocol-deviation reporting
Resolve site performance issues and recommend and track CAPAs
Perform site qualification, initiation, routine monitoring, and close-out visits
Perform remote and centralized monitoring and aggregate site/study data review
Develop and maintain clinical study files and support eTMF reconciliation
Assist with SAE case-management reconciliation
Maintain study tracking in CTMS or other tools
Report site updates and project risks to the Clinical Trial Manager and/or Lead CRA
Support grant reconciliations, clinical study report quality checks, and safety-narrative drafting
Meet department KPIs and propose improvements
Attend project meetings and teleconferences and potentially present at Investigator Meetings
Support site audits and inspections and respond to identified issues
Maintain scientific knowledge in the project therapeutic area
Maintain effective communication among sites, clinical teams, and sponsors
Contribute to SOPs, manuals, templates, budgets, proposals, client materials, and process initiatives
Participate in business development, recruiting, hiring, thought leadership, and knowledge-sharing activities
Train junior CRAs, lead team trainings, support contract CRA onboarding and management, and participate in resource assignments
Perform other duties as required

Requirements

What you’ll need

Bachelor’s degree in a scientific discipline required
Candidates with clinical training/licensure (e.g., RN, LPN) and relevant experience will also be considered
Minimum of 10 years of CRA experience required
Oncology experience highly preferred
Ability to travel as needed (anticipated at 40%–60% of time)
Excellent written and oral communication skills
Excellent organizational skills and astute attention to detail
Ability to function effectively as a study monitor with limited supervision
Prior experience observing and training junior CRAs, or performing GCP audits, is a plus
Familiarity with PCs and standard Microsoft Office software applications
Familiarity with Medidata technical tools, including Rave EDC, RCM eTMF, CTMS, Medical Imaging, TSDV, and Patient Cloud
Ability to meet the stated physical requirements, with or without accommodation