Clinical Research Associate II; US West FSP

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…