WHY THIS ROLE EXISTS
Clinical trials don't succeed at headquarters. They succeed at sites—where investigators enroll patients, where data gets recorded, where questions get answered.
The Clinical Research Associate is the person who makes sure sites succeed.
You're PAREXEL's direct connection to investigators and site staff. You evaluate whether studies are being implemented correctly. You identify issues before they become problems. You build relationships that make sites want to work with us again.
Without strong CRAs, trials fail. With you, they deliver.
THE BASICS
Role: Clinical Research Associate II / Senior CRA
Company: PAREXEL
Location: Field-based (specific location flexible)
Employment Type: Full-time
Education: Degree in biological science, pharmacy, health-related discipline, or equivalent nursing qualification
Experience: Site management or equivalent clinical research experience
Travel: Extensive, including on-site visits and occasional overnight
WHAT YOU'LL OWN
Site Relationships
You're the face of PAREXEL to your assigned sites. You build trust with investigators and coordinators. You make them want to work with you—not because they have to, but because you make their jobs easier.
Study Integrity
You assess whether studies are being implemented according to protocol. You spot issues with documentation, training, or performance. You address them before they become systemic problems.
Problem Resolution
When sites have issues—training gaps, documentation deficiencies, questions about processes—you resolve them. You don't just report problems; you fix them.
Compliance
You ensure sites remain audit and inspection ready at all times. You maintain deep knowledge of ICH-GCP and local regulations. You hold the standard.
Data Quality
You evaluate potential data quality and integrity issues. You apply judgment to determine what matters and what needs follow-up. You protect the integrity of the trial.
Site Visits
You perform qualification visits, initiation visits, monitoring visits, and close-out visits. You generate reports. You follow up. You close the loop on every action.
Trial Management Systems
You keep CTMS, EDC, IVRS, and other systems updated and accurate. You ensure site-level data is complete and timely. You manage TMF documentation with first-time quality.
Team Collaboration
You work with your team to meet project goals. You support others where needed. You communicate openly and constructively.
Self-Management
You work independently, with limited oversight. You manage your time across multiple sites and priorities. You keep your manager informed without being chased.
RESPONSIBILITIES IN DETAIL
From Site Identification Through Close-Out
Site Start-Up
- Facilitate site access to relevant study systems
- Ensure site staff complete required training
- Collect and review regulatory documentation
- Perform qualification visits and assess site facilities
Ongoing Site Management
- Build and maintain relationships with investigators and coordinators
- Monitor recruitment plans and suggest improvements
- Review CRF data entry and query status
- Follow up on SAEs and ensure proper documentation
- Manage test article and study supply accountability
- Review site payment status and follow up as needed
Issue Identification and Resolution
- Evaluate if on-site staff assignments remain accurate
- Identify training needs and implement corrective actions
- Address documentation deficiencies
- Resolve issues pending from previous visits
- Follow up on site questions with timely responses
Data Quality
- Identify and evaluate potential data quality and integrity issues
- Determine appropriate follow-up actions
- Apply judgment to distinguish critical issues from minor concerns
Visits and Reporting
- Perform qualification, initiation, monitoring, and close-out visits
- Conduct remote contacts as needed
- Generate accurate visit/contact reports
- Document all actions and follow-up items
Compliance and Documentation
- Ensure sites remain audit and inspection ready
- Manage TMF documentation with first-time quality
- Distribute study documents to sites
- Maintain Investigator Site Files
Team Contribution
- Participate in investigator meetings and internal meetings
- Support audits and regulatory inspections as required
- Delegate administrative tasks appropriately
- Guide and support Administrative Support Team members
- Provide input for team performance conversations
Personal Development
- Develop expertise to become a subject matter expert
- Proactively seek guidance when needed
- Complete administrative tasks (timesheets, expenses, metrics) on time
- Keep manager informed of progress and issues
WHAT YOU'LL BRING
Experience
- Site management experience in clinical research
- Understanding of clinical trials methodology and terminology
- Proven ability to work independently with limited oversight
Knowledge
- ICH-GCP Guidelines and applicable international/local regulations
- Clinical Trial Management Systems (CTMS)
- Electronic Document Management Systems (EDMS)
- Microsoft Office applications (Excel, Word)
Skills
- Sound problem-solving abilities
- Strong presentation skills
- Client-focused approach
- Ability to prioritize multiple tasks and meet timelines
- Analytical thinking and autonomous decision-making
- Strong interpersonal, verbal, and written communication
- Attention to detail
- Time management and sense of urgency
- Ability to work across cultures and in virtual teams
- Consulting mindset
Practical Requirements
- Extensive travel as required by study assignments
- Valid driver's license
- Flexible attitude toward work assignments and new learning
HOW WE MEASURE SUCCESS
Site Performance
Sites meet enrollment targets. Data is clean and entered on time. Issues are resolved quickly.
Compliance
Sites remain inspection ready. Documentation is complete and accurate. No critical findings during audits.
Relationships
Investigators and coordinators want you as their CRA. They respond to your requests. They partner with you.
Team Contribution
You meet project goals. You support colleagues. You communicate effectively.
Personal Accountability
Timesheets, expenses, and metrics are submitted on time. Manager is informed without needing to chase. You proactively seek guidance when needed.
WHY PAREXEL
Global Leader
PAREXEL is a world-leading clinical research organization. We're part of the team that brings new therapies to patients.
Career Development
We invest in our people. There are clear paths for growth, opportunities to develop expertise, and support for your professional journey.
Field-Based Flexibility
You work from the field, managing your own schedule and territory. We trust you to do your job.
Supportive Culture
We work in matrix environments. We value teamwork. We support each other.
Meaningful Work
Every trial you monitor brings new treatments closer to patients. Your work matters.
QUESTIONS TO ASK YOURSELF
Do I have site management or clinical research experience?
Am I comfortable working independently with limited oversight?
Can I build relationships with investigators and site staff?
Do I have strong problem-solving and analytical skills?
Am I willing to travel extensively for site visits?
Can I prioritize multiple tasks and meet tight deadlines?
Do I want my work to directly contribute to bringing new therapies to patients?
APPLICATION PROCESS
- Submit your application through the PAREXEL careers portal
- Applications reviewed by the hiring team
- Qualified candidates contacted for initial conversation
- Interviews with clinical operations leadership
- Decision and offer communicated
READY TO APPLY?
If you're an experienced CRA ready to take ownership of site performance, build meaningful relationships, and deliver high-quality clinical trials—apply now.
Include:
- Your resume highlighting site management experience
- Brief note on your therapeutic areas of expertise
- Why you're interested in PAREXEL
Join PAREXEL. Make trials succeed.
- PAREXEL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified candidates. If you need accommodations during the application process, please let us know.
