Clinical Research Associate II (US West) - FSP

Parexel•Southport, NC

About The Position

The Clinical Research Associate (CRA) acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. The role includes conducting remote and on-site monitoring, supporting site readiness and selection, maintaining regulatory and trial documentation, communicating with investigators and site staff, and addressing site performance, quality, and compliance issues. The CRA also contributes to team development, supports audit and inspection activities, and complies with Parexel and client standards.

Requirements

At least 2 years of direct site monitoring experience in bio/pharma/CRO.
Fluency in local languages and English, verbally and in writing, with strong communication skills and the ability to understand and present technical information effectively.
Good understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, and country clinical research laws and guidelines.
Good understanding of global and country/regional clinical research guidelines and ability to work within them.
Hands-on knowledge of Good Documentation Practices.
Proven site management skills, including site performance management and patient recruitment.
Strong monitoring skills and independent professional judgment.
Good IT skills, including MS Office and clinical IT applications on computers, tablets, and mobile devices, with the ability to adapt to new applications and devices.
Ability to understand and analyze data and metrics and act appropriately.
Ability to manage complex issues in a solution-oriented manner, conduct root cause analysis, and implement preventive and corrective actions.
Effective time management, organizational, interpersonal, conflict management, and problem-solving skills.
Ability to work independently across multiple protocols, sites, and therapy areas.
Strong accountability and urgency, with the ability to set priorities and handle multiple tasks in a changing environment.
Ability to work effectively in a multicultural matrix environment and establish and maintain culturally sensitive working relationships.
Customer focus and a strong quality and compliance mindset.
Positive and growth mindset, self-direction, and professional demeanor and communication consistent with organizational policies and practices.

Nice To Haves

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

Responsibilities

Build and maintain strong site relationships through all phases of the trial.
Conduct clinical study site management and monitoring in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, the protocol, the Site Monitoring Plan, and associated documents.
Develop an in-depth understanding of the study protocol and related procedures.
Coordinate tasks with other sponsor roles to achieve site readiness.
Participate in and provide input on site selection and validation activities.
Perform remote and on-site monitoring and oversight to ensure site data are complete, accurate, and unbiased, and that subjects’ rights, safety, and well-being are protected.
Conduct validation, initiation, monitoring, closeout, and other site visits; prepare clear, comprehensive, and accurate visit and non-visit contact reports in a timely manner.
Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
Communicate with investigators and site staff about protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits and inspections, and overall site performance.
Identify, assess, and resolve site performance, quality, or compliance problems; escalate issues as appropriate in collaboration with the Clinical Research Manager and Partner Line Manager.
Maintain information and documentation in the Clinical Trial Management System, electronic Trial Master File, and other applicable systems within required timelines.
Contribute to CRA team knowledge as a process subject matter expert, buddy or mentor, and by sharing best practices.
Support or lead audit and inspection activities as needed and perform co-monitoring visits where appropriate.
Complete required training, timesheets, expense reports, and CV updates; maintain knowledge of and comply with Parexel and client processes, ICH-GCP, and other applicable requirements.