Clinical Research Associate

Position Overview

This role involves monitoring investigator sites using a risk-based approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions. The goal is to ensure site compliance and reduce risks. Responsibilities include ensuring data accuracy through reviews, assessing investigational product, documenting observations, and escalating issues to clinical management for timely resolution.

Employment Type

• Full-time

Work Schedule

• Standard (Monday-Friday)

Environmental Conditions

• Office

Responsibilities

• Monitor investigator sites with a risk-based monitoring approach.
• Apply root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failures and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Maintain regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with other project team members for issue/finding resolution.
• Investigate and follow-up on findings as applicable.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Perform trial close-out and retrieval of trial materials.
• Ensure required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).
• Facilitate effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.
• Respond to company, client, and applicable regulatory requirements/audits/inspections.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to the project team by assisting in the preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contribute to other project work and initiatives for process improvement, as required.

Location Type

• [Information not provided]

Salary

• [Information not provided]