FSP CRA I/II (Oncology & Cell Therapy)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as an FSP CRA– Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you will support innovative Cell Therapy clinical trials and contribute to the advancement of transformational treatments for patients with hematologic malignancies and other diseases.

As an FSP CRA, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments. Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.

You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You'll Do: • Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process gaps and implement appropriate corrective and preventive actions (CAPA).

• Perform on-site and remote monitoring activities, including SDR, SDV, CRF review, and investigational product accountability, to ensure protocol compliance, subject safety, and data integrity. • Prepare monitoring reports, follow-up letters, and other study documentation in a timely manner using approved business writing standards. Escalate site issues and follow them through to resolution in collaboration with clinical management and the project team • Maintain regular communication with investigative sites between monitoring visits to ensure protocol adherence, timely data entry, and resolution of outstanding issues.

• Support investigator payment activities and contribute to the timely resolution of monitoring findings in partnership with cross-functional project team members. • Participate in investigator meetings and support site identification, qualification, initiation, and close-out activities in accordance with study requirements, applicable regulations, and ICH-GCP. Ensure essential documents are complete, accurate, and maintained in accordance with ICH-GCP, applicable regulations, and project requirements.

Conduct on-site file reviews as specified by the study. • Provide regular trial status updates to the Clinical Team Manager (CTM) and maintain study systems, including the Clinical Trial Management System (CTMS), according to established study conventions. • Facilitate effective communication among investigative sites, the client, and the project team through written, verbal, and electronic interactions.

Support company, client, and regulatory audits and inspections as required. • Complete administrative responsibilities, including expense reports and timesheets, accurately and within required timelines. • Contribute to study deliverables, project tools, and process improvement initiatives. Demonstrate flexibility by supporting cross-functional activities and project-related tasks as business needs evolve.

• The role may involve a broader mix of clinical operations and project support activities to meet study and business needs. Candidates who are adaptable, collaborative, and willing to take on a variety of responsibilities while developing within the role will be well suited for this position. Education and Experience Requirements: • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

• Previous experience that provides the knowledge, skills, and