New · posted Nov 8
Parexel · Pharmaceuticals
Senior Clinical Research Associate - FSP
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
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 the client’s credibility, scientific leadership and in order to facilitate the client’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
Compliance with Parexel standards
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required.
- Updates Curriculum Vitae (CV) as required
- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
What you need
Education
- Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
- Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
- Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
- Global clinical trial experience
- Must be fluent in English and in the native language(s) of the country they will work in
- Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
- 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
What you'll do
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 client 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
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.
Preferably West/Pacific/West Coast and Central US
Positions with Oncology and Non-Oncology Experience
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 8, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US63 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $109,250 | $124,500 | $126,750 |
Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 238 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 41 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct23
- Investigations and CAPA12
- Collaboration and leadership11
- GMP and compliance5
- Documentation and SOPs5
- Lab testing and methods1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Research work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
Parexel on Regulatory Jobs
- 51
- Open roles
- 51
- Distinct roles
- 6
- Locations
By discipline
- Clinical33 65%
- Regulatory17 33%
- Quality1 2%
By level
- Senior & Principal33 65%
- Manager11 22%
- Associate & Specialist6 12%
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Senior Clinical Research Associate - FSP at Parexel
Open until filled.