Senior Clinical Research Associate

Parexel

. Act as the primary site contact and site manager throughout all phases of a clinical research study .

Posted 9/18/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research site management, including compliance with ICH-GCP and local regulations, while effectively mentoring junior CRAs and managing site performance. Proficient in data analysis and maintaining documentation in clinical trial management systems.

Highest-signal resume keywords

Clinical Research Site ManagementICH-GCP ComplianceSite Performance MonitoringData Analysis SkillsMentoring Junior CRAs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial PhasesGood Documentation PracticesSite Selection and ValidationRegulatory Documentation ManagementRoot Cause AnalysisPatient Recruitment StrategiesMonitoring and Oversight ActivitiesIndependent Professional JudgmentTime ManagementProblem-Solving

Soft Skills

Interpersonal SkillsConflict ManagementOrganizational SkillsEffective CommunicationCustomer Focus

Tools & Technologies

CTMSETMFMS OfficeClinical IT Applications

Industry Keywords

Bio/PharmaCROClinical Research GuidelinesClinical Study ProtocolsMulticultural Environment

About the role

Key responsibilities & impact

Act as the primary site contact and site manager throughout all phases of a clinical research study
Take overall responsibility for allocated sites
Develop strong site relationships and ensure continuity throughout all trial phases
Perform clinical study site management and monitoring activities in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plan, and associated documents
Gain in-depth understanding of the study protocol and related procedures
Coordinate and manage tasks with sponsor roles to achieve Site Ready
Participate in site selection and validation activities
Perform remote and on-site monitoring and oversight activities
Conduct validation, initiation, monitoring, and close-out visits
Prepare timely, clear, comprehensive, and accurate visit and non-visit contact reports
Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance
Identify, assess, resolve, and escalate site performance, quality, or compliance problems
Collaborate with internal functional teams, vendors, IRBs/IECs, and regulatory authorities
Maintain information and documentation in CTMS, eTMF, and other systems
Act as a process subject matter expert, share best practices, and provide training
Support or lead audit/inspection activities
Mentor or buddy junior CRAs and perform co-monitoring visits
Contribute to business initiatives and projects
Complete required training, timesheets, expense reports, and CV updates

Requirements

What you’ll need

Fluent in local languages and English (verbal and written)
Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH, and country clinical research law and guidelines
Hands-on knowledge of Good Documentation Practices
Excellent understanding of global, country/regional clinical research guidelines
Demonstrated ability to mentor/lead
Proven site management skills, including independent management of site performance and patient recruitment
Demonstrated high-level monitoring skill with independent professional judgment
Good IT skills, including MS Office and clinical IT applications on computer, tablet, and mobile devices
Ability to understand and analyze data/metrics
Experience conducting site motivational visits to boost site enrollment
Ability to manage complex issues and work in a solution-oriented manner
Ability to perform root cause analysis and implement preventive and corrective action
Ability to mentor junior CRAs and perform co-monitoring visits
Effective time management, organizational, interpersonal, conflict management, and problem-solving skills
Ability to work independently across multiple protocols, sites, and therapy areas
Ability to set priorities and handle multiple tasks in a changing environment
Ability to work effectively in a matrix multicultural environment
Commitment to customer focus and quality/compliance
Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week
Current driver's license required
Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO
Bachelor's degree preferred with a strong emphasis in science and/or biology