Senior Clinical Research Associate/Clinical Research Associate II - US Any Region - FSP

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Senior Clinical Research Associate/Clinical Research Associate II - US Any Region - FSP

Primary Location: United States, Remote Job ID R0000034865 Category Clinical Trials Date Posted 08/19/2025

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• Success profile
• About this role
• Potential career path
• Employee insights
• Our team
• Why Clinical Research Associates work at Parexel
• Learn about our culture

Overview

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Flexible
• Organized
• Problem-solver
• Self-starter

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About This Role

Job Purpose:

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.

Key Accountabilities

Oversight of Monitoring Responsibilities and Study Conduct

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
• Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
• Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and
• recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
• Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
• Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
• Support database release as needed
• May undertake the responsibilities of an unblinded monitor where appropriate

Clinical/Scientific and Site Monitoring Risk

• Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
• Interact with investigator site heath care professionals in a manner which enhances sponsor’s credibility, scientific leadership and in order to facilitate sponsor’s clinical development goals
• Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
• Drive Quality Event (QE) remediation, when applicable
• Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable

Collaboration

• Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)
• Partners with SCP and Country Study Operations Manager (SOM)
• When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)
• May act as a Mentor for Clinical Research Associates

Skills

• Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
• Preferred therapeutic experience in Oncology
• Global clinical trial experience preferred
• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
• Must be fluent in English and in the native language(s) of the country they will work in
• Travel (60-80%) within area is required
• Valid driver’s license and passport required

Knowledge And Experience

• Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
• Demonstrated knowledge of global and local regulatory requirements
• Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
• Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
• Demonstrated ability to support sponsor regulatory interactions/inspections
• Demonstrated knowledge of the processes around protocol design and feasibility assessment
• Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
• Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
• Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

Education

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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Potential Career Path

Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.

• APEX CRA
• CRA I
• CRA II
• Senior CRA
• Project Management

Subject Matter Expert

People Management

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Employee Insights

Nick on a day in the life of a CRA

Nick Burger | Senior Clinical Research Associate

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Liliana on CRA tasks and our recognition program

Liliana Belmares Flores | CRA Line Manager

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Marlayna on why Parexel is a great place for CRAs

Marlayna Fitts | CRA Line Manager

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TEAM IMPRESSIONS

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Why Clinical Research Associates work at Parexel

Patient-focused in everything we do

We push the boundaries of what is possible to create clinical trials that are inclusive, innovative, and patient-focused

Supportive and inclusive environment

We foster collaboration, teamwork, respect, and inclusivity, to work together to achieve common goals.

Career growth and development

We develop your skills through training, mentorship, and career advancement programs.

Flexible work arrangements

We focus on outputs and results, not where and when you work.

Diverse therapeutic areas and project exposure

We continuously learn from a broad exposure from early to late phase clinical trials and our cros-functional global teams.

Advanced Technology

We recognize the importance of first-time quality to bring treatments to patients faster.

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Learn About Our Culture

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