CRA/Sr CRA - Client decicated (FSP)

Clinical Research Associate – Senior (Client-Dedicated, FSP)

Join our esteemed team as a **Senior Clinical Research Associate (CRA)** and play a pivotal role in advancing global healthcare innovation. With a proven track record of supporting the world’s leading pharmaceutical companies and over 750 biotech organizations, we are at the forefront of clinical research, conducting more than 2,700 trials across 100+ countries. This is an opportunity to contribute to groundbreaking medical advancements while honing your expertise in a dynamic, collaborative environment.

As a **Senior CRA**, you will lead and oversee all aspects of clinical monitoring and site management, ensuring the highest standards of compliance, data integrity, and patient safety. Your strategic leadership will be instrumental in maintaining regulatory adherence, optimizing trial efficiency, and fostering strong partnerships with investigative sites and sponsors.

Key Responsibilities

Your role will encompass a broad spectrum of critical functions, including:

• Risk-Based Monitoring & Compliance: Implement a proactive risk-based monitoring approach to identify site process failures, conduct root cause analysis (RCA), and implement corrective/preventive actions to mitigate risks. Ensure data accuracy through source data review (SDR), source data verification (SDV), and CRF assessments during both on-site and remote monitoring activities.
• Investigational Product & Documentation Management: Assess investigational products through physical inventory reviews and documentation audits. Document observations meticulously in compliance with approved business writing standards, escalating deficiencies promptly to clinical management and ensuring timely resolution.
• Site Engagement & Collaboration: Maintain regular communication with investigative sites to confirm protocol adherence, resolve prior issues, and ensure timely data recording. Act as a liaison between sites, client companies, and the project team, facilitating seamless collaboration through written, verbal, and electronic channels.
• Study Initiation & Close-Out: Identify and onboard qualified investigative sites in collaboration with client stakeholders. Oversee trial initiation, compliance with ICH-GCP guidelines, and regulatory obligations, while ensuring a smooth close-out process and retrieval of trial materials.
• Audit Readiness & Documentation: Ensure all essential study documents are complete, accurate, and compliant with ICH-GCP and regulatory requirements. Conduct on-site file reviews and maintain audit readiness to withstand inspections and evaluations.
• Progress Tracking & Reporting: Provide regular trial status updates and progress reports to the Clinical Team Manager (CTM), ensuring alignment with study systems and agreed-upon conventions (e.g., Clinical Trial Management Systems).
• Process Improvement & Team Contribution: Actively participate in project publications, share best practices with team members, and contribute to initiatives aimed at enhancing clinical trial processes and operational efficiency.
• Administrative & Compliance Support: Manage administrative tasks such as expense reports and timesheets with precision and timeliness. Adhere to company policies, client requirements, and regulatory guidelines to ensure seamless trial execution.

This role demands a blend of technical expertise, analytical rigor, and interpersonal finesse. You will thrive in a fast-paced, client-centric environment where your strategic insights and collaborative spirit drive meaningful outcomes in clinical research.

Qualifications & Experience

To excel in this position, you will bring:

• A Bachelor’s degree in a life sciences-related field or a Registered Nursing certification, complemented by relevant formal academic or vocational qualifications.
• Proven experience as a Clinical Research Associate (CRA), with a preference for those holding Senior CRA or equivalent leadership experience in monitoring, site management, or related roles.
• Demonstrable expertise in ICH-GCP guidelines, regulatory compliance, and clinical trial operations, with a strong understanding of FSP (Full Service Provider) monitoring environments.
• Exceptional problem-solving and critical thinking skills, with the ability to apply risk-based methodologies to optimize trial efficiency.
• Superior communication and stakeholder management abilities, enabling effective collaboration with investigative sites, sponsors, and cross-functional teams.
• Familiarity with clinical trial management systems, data verification tools, and regulatory documentation standards.
• A commitment to continuous improvement, process optimization, and adherence to the highest ethical and professional standards in clinical research.

If you are passionate about advancing medical science and eager to take on a leadership role in clinical trials, we invite you to be part of our mission. Join us in shaping the future of healthcare—one trial at a time.