New · posted Nov 1
Parexel · Pharmaceuticals
Senior Clinical Research Associate - Early Development - Central/NE Region - FSP
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
The SrCRA role is responsible for supporting monitoring and site management activities for the client Sponsored studies. Site monitoring and site management activities are conducted according to ICH GCP, applicable country/local regulations and client SOPs. Site interactions are conducted both on-site and off-site with documented interactions recorded in CTMS. The role involves collaboration with cross-functional clinical study teams and investigator site personnel to ensure study deliverables are met efficiently and effectively. The SrCRA is also responsible for the oversight of activities carried out at investigator sites where the monitoring may be supported by a CRO partner through the review of operational data and metrics.
What you need
Bachelor's degree (or equivalent)
Experience
- Minimum of 5 years of related experience for Snr CRA
- Strong analytical problem-solving skills and critical thinking abilities.
- Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).
- Effective communication and interpersonal skills to build relationships internally and externally.
- Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.
- Demonstrated ability to deliver clear and concise written reports.
- Effective prioritization and time management skills
What you'll do
Site Management and Monitoring Activities
- Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs.
- Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
- Partner with Clinical Trial Liaison (CTL) and other client functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables.
- Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct.
- Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements
Oversight Monitoring
- Prepare and maintain Oversight Monitoring Plan
- Perform review of study metrics, assess CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits
- Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA
- Review site source documentation and verify accurate data capture (ALCOA principles)
- Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items
Documentation and Reporting
- Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting.
- Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner.
- Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents).
Issue Management and Escalation
- Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary.
- Track, trend, and report issues, escalating them to the appropriate teams when required.
Collaboration and Communication
- Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.
- Actively participate in team meetings and process improvement initiatives to enhance study outcomes.
Inspection Readiness
- Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables
From the posting
About Parexel
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Equal opportunity, accessibility and legal noticesParexel's statements, word for word
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US51 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $120,250 | $124,500 | $130,500 |
Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 210 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not Parexel's own promotion track.
Career resources on Clinical Research
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct13
- Documentation and SOPs10
- GMP and compliance6
- Investigations and CAPA6
- Collaboration and leadership6
- Data and digital systems2
- Lab testing and methods1
- Validation and qualification1
- Regulatory submissions1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
Company hiring pulse
Parexel on Regulatory Jobs
- 47
- Open roles
- 46
- Distinct roles
- 6
- Locations
By discipline
- Clinical28 60%
- Regulatory18 38%
- Quality1 2%
By level
- Senior & Principal31 66%
- Manager10 21%
- Associate & Specialist5 11%
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Senior Clinical Research Associate - Early Development - Central/NE Region - FSP at Parexel
Open until filled.