Clinical Research Associate

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process. This role is crucial for ensuring that clinical trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and Standard Operating Procedures (SOPs), thereby safeguarding subject rights, well-being, and data reliability. The CRA acts as a site processes specialist, ensuring audit readiness and developing collaborative relationships with investigational sites. Detailed tasks and responsibilities are outlined in the task matrix.

A Day in the Life

• Monitors investigator sites using a risk-based monitoring approach.
• Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and decrease risks.
• Ensures data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review via on-site and remote monitoring activities.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Expeditiously communicates observed deficiencies and issues to clinical management and follows all issues through to resolution.
• Maintains regular contact with investigative sites between monitoring visits to confirm protocol adherence, resolution of identified issues, and timely data recording.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Shares responsibility with other project team members for issue/finding resolution.
• Investigates and follows up on findings as applicable.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS).
• Performs Quality Control (QC) checks of reports generated from the CTMS system where required.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to relevant procedures to ensure compliance with protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Ensures trial close-out and retrieval of trial materials.
• Ensures required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions with team members.
• Performs additional study tasks as assigned by the CTM (e.g., trip report review, newsletter creation, lead CRA team calls).
• Facilitates effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.
• Responds to company, client, and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to other project work and initiatives for process improvement, as required.

Requirements

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Application Instructions

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Company Information

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