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Parexel · 3 hours ago

Sr. Clinical Research Associate - Oncology - TX or CO - FSP

United States

Full-time

Hybrid

Mid, Senior Level

3+ years exp

Parexel is a leading company in the clinical research industry, and they are seeking a Senior Clinical Research Associate to manage and monitor clinical trials. The role involves ensuring patient safety and quality execution of clinical studies while maintaining effective relationships with investigator sites and managing protocol-related issues.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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 Site Care Partner 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 Site Care Partner 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

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 Sponsor's credibility, scientific leadership and in order to facilitate their 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

Qualification

Clinical trial methodologiesICH/GCP regulationsMonitoring experienceOncology experienceFDA regulationsLife sciences degreeFluent in English

Required

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)

Must be fluent in English and in the native language(s) of the country they will work in

Ability to travel 60-80%

Valid driver's license and passport required

Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Preferred

Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

Company

Parexel

Glassdoor3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)