Clinical Research Associate II/Sr. Clinical Research Associate - West Coast - FSP

Clinical Research Associate II/Sr. Clinical Research Associate - West Coast - FSP

Tags

83

GOOD MATCH

Experience Level

100

Skill

81

Industry Exp.

68

Clinical Trials

Pharmaceutical

Biotechnology

Consulting

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

Benefits

Remote work in Colorado, United States

Glassdoor

3.8

Global clinical research and biopharmaceutical services company.

Raleigh, North Carolina, USA

http://www.parexel.com

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Education and Training

Engineering and Development

Management and Executive

Accounting and Finance

Legal and Compliance

Customer Service and Support

Sales

Marketing

Human Resources

Trends of Total Sponsorships

*2026

(38)

2025

(31)

2024

(46)

2023

(41)

2022

(51)

2021

(54)

Qualifications

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations

Minimum 2 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

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

Required skills

Clinical Trial Methodologies, Clinical Research Site Monitoring, ICH/GCP, FDA Regulations, Clinical Trial Regulations, Clinical Trial Site Management, Investigational Product Management

Experience

2+ years