Clinical Research Associate

allied executive solutions

. Conduct site selection, initiation, routine monitoring, and close-out visits according to the monitoring plan .

Posted 9/18/2026contractNew Jersey • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical trial monitoring, including site selection, data verification, and compliance with ICH-GCP and regulatory requirements. Proficient in maintaining trial documentation and fostering relationships with site staff to ensure patient safety and data integrity.

Highest-signal resume keywords

Clinical Trial MonitoringICH-GCP GuidelinesElectronic Data Capture (EDC) SystemsSource Data Verification (SDV)Clinical Trial Management Systems (CTMS)

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

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

Hard Skills

Source Data Review (SDR)Data Discrepancy ResolutionTrial Master File (TMF) ManagementProtocol Deviation DocumentationRisk-Based Monitoring (RBM)

Soft Skills

Attention to DetailAnalytical SkillsWritten CommunicationVerbal CommunicationRelationship Building

Certifications & Qualifications

CCRASoCRAACRP

Industry Keywords

Clinical ResearchPatient SafetyRegulatory ComplianceInvestigational Product AccountabilityTherapeutic Area Experience

About the role

Key responsibilities & impact

Conduct site selection, initiation, routine monitoring, and close-out visits according to the monitoring plan
Verify informed consent procedures and protection of patient rights and safety
Perform source data verification (SDV) and source data review (SDR)
Review and reconcile clinical trial data against source documents
Query and resolve data discrepancies with site staff
Monitor investigational product accountability, storage, and dispensing
Assess site compliance with the protocol, ICH-GCP, and applicable regulations
Identify, document, and escalate protocol deviations, adverse events, and serious adverse events
Maintain and review the Trial Master File (TMF) and site regulatory files
Build and maintain relationships with investigators, site coordinators, and study staff
Track site performance metrics, including enrollment, query resolution, and data entry timelines
Prepare monitoring visit reports and follow-up letters
Support site staff training on protocols, study procedures, and data entry systems
Assist with audit and regulatory inspection preparation and follow-up
Act as the primary point of contact between the sponsor/CRO and investigative sites
Safeguard data integrity and patient safety throughout the trial lifecycle
Uphold the organization’s mission, values, and commitment to ethical research
Participate in training, team meetings, quality improvement, accountability, collaboration, and continuous learning activities

Requirements

What you’ll need

Bachelor's degree in life sciences, nursing, pharmacy, or a related field
1–3+ years of experience as a CRA, clinical trial monitor, or in a clinical research role
Entry-level candidates with strong clinical/research backgrounds may be considered for Associate CRA positions
Working knowledge of ICH-GCP guidelines and relevant regulatory requirements, including FDA and EMA
Familiarity with clinical trial monitoring processes, including SDV/SDR and query management
Experience with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS)
Strong attention to detail and analytical skills
Excellent written and verbal communication skills
Ability to travel to investigational sites as required
CCRA, SoCRA, or ACRP certification preferred
Experience monitoring multi-site or global clinical trials preferred
Relevant therapeutic area experience, such as oncology, cardiology, or CNS, preferred
Experience with risk-based monitoring (RBM) approaches preferred
Ability to work in clinical, office, hybrid, or community-based settings as required
Some local travel, evening hours, or flexible scheduling may be required depending on study needs
Must follow organizational policies, research protocols, regulatory requirements, and compliance standards
Must maintain accurate documentation and timely communication
Must protect research participant rights, safety, dignity, and confidentiality

Benefits

Comp & perks

Equal opportunity employment and non-discrimination commitment
Training, team meetings, quality improvement activities, and performance review processes
Flexible scheduling may be available depending on study needs