US Locations - FSP

Parexel

21h•Hybrid

About The Position

At Parexel, the Senior Clinical Research Associate (Sr. CRA) plays a crucial role in improving global health by managing, monitoring, and closing out assigned clinical trial investigator sites. This ensures patient safety and high-quality study execution, adhering to prevailing laws, Good Clinical Practices (GCP), and Sponsor standards. The Sr. CRA is responsible for maintaining strong relationships with investigator sites, facilitating effective delivery of clinical trials (e.g., enrollment, database release), safeguarding site quality and compliance, and enhancing the company's reputation. They are also tasked with resolving all protocol-related issues for their assigned sites, collaborating closely with the Site Care Partner (SCP) and other study team members throughout the trial's setup, execution, and close-out phases.

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Minimum 3 years relevant experience in clinical research site monitoring
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

Nice To Haves

Preferably 2 years in Oncology monitoring experience
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

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