Thermo Fisher / PPD
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 abilities to perform the job, including a minimum of 3 years of clinical research monitoring experience.
• Experience monitoring Oncology and/or Hematology clinical studies is strongly preferred.
• Experience supporting Cell Therapy, Gene Therapy, or other advanced therapeutic modality studies is considered an asset.
Knowledge, Skills and Abilities:
• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexibile and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
Working Conditions and Environment:
• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions