Clinical Research Associate II (US West) - FSP

Parexel; Topeka (KS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Remote work

Job summary

Parexel seeks a Clinical Research Associate to manage clinical trial sites and serve as primary contact across all phases. You will monitor sites, ensure regulatory compliance, and maintain high-quality data while safeguarding participant safety.

Role requires collaboration with investigators, remote/on-site monitoring, and contributing to audits in a fast-paced, matrix environment.

Qualifications

• Minimum two years of direct site monitoring experience is required.
• Strong knowledge of ICH-GCP and regulatory guidelines.
• Experience with site selection and regulatory documentation.

Responsibilities

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
• Performs site management/monitoring activities
• Gains understanding of the study protocol and related procedures
• Coordinates tasks with sponsor roles to achieve Site Ready
• Participates and provides inputs on site selection and validation
• Performs remote and on-site monitoring and oversight
• Data at site is complete, accurate and unbiased
• Subjects’ safety and well-being are protected
• Conducts site visits (validation, initiation, monitoring, closeout)
• Collects regulatory documentation for start-up, maintenance and close-out
• Communicates with investigators on protocol, recruitment and regulatory issues
• Identifies and escalates site performance or compliance issues
• Manages documentation in CTMS and eTMF

Skills

Clinical research

Site management

Monitoring

Communication

GCP/ICH

Data analysis

Documentation

MS Office

Education

Bachelor’s degree in science

Tools

Clinical Trial Management System

eTMF

Job description

Job Overview

The Clinical Research Associate acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for the allocated sites.

Key Accountabilities

Site Management Responsibilities

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
• Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents
• Gains an in-depth understanding of the study protocol and related procedures
• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
• Participates and provides inputs on site selection and validation activities
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
• Data generated at site are complete, accurate and unbiased
• Subjects’ right, safety and well-being are protected
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
• Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager
• Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines

Team Development and Support

• Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required
• Supports and/or leads audits/inspection activities as needed
• Performs co-monitoring visits where appropriate

Compliance with Parexel Standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements

Skills

• Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Hands on knowledge of Good Documentation Practices
• Proven skills in Site Management including management of site performance and patient recruitment
• Demonstrated high level of monitoring skill with independent professional judgement
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
• Ability to understand and analyze data/metrics and act appropriately
• Capable of managing complex issues, working solution-oriented manner
• Performs root cause analysis and implements preventative and corrective action
• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
• Demonstrated high level of monitoring skill with independent professional judgement
• Able to work highly independently across multiple protocols, sites, and therapy areas
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus
• Works with high quality and compliance mindset
• Positive mindset, growth mindset, capable of working independently and being self-driven
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices

Knowledge and Experience

• Minimum 2 years of direct site monitoring experience in bio/pharma/CRO

Note: Specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs.

Education

• Bachelor’s degree preferred with a strong emphasis in science and /or biology

#LI-REMOTE

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.