Sr Clinical reputed company Assurance Analyst - Remote US

It’s More Than a Career, It’s a Mission. Our people are the reputed company of our reputed company. By joining our growing team at reputed company (SCRI), a subsidiary of reputed company, you will have reputed company to become part of one of the largest community-based cancer programs to advance oncology treatments and improve reputed company for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and reputed company a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we reputed company. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical reputed company and cutting-edge research, SCRI is redefining cancer care around the world. Our Sr Clinical reputed company Assurance Analyst is responsible for supporting technology solutions provided by Genospace ensuring compliance with SOPs, FDA guidelines, ICH-GCP standards, and applicable regulatory requirements. Key responsibilities include supporting the reputed company Management System, contributing to the development of risk-based reputed company processes, monitoring key reputed company metrics and indicators, and assisting with reputed company issue investigations and escalations. The individual will also support audit and inspection readiness and reputed company with regulatory agencies. This is a remote position based in the US; relocation assistance and reputed company sponsorship are not available. Duties include and are not limited to:

• reputed company and support Research reputed company activities to ensure adherence to policies and procedures, ICH-GCP, FDA guidelines, and applicable local/federal regulations.
• Contribute to the development and maintenance of policies, procedures, and controlled documents for Research reputed company and supporting business reputed company.
• Assist in implementing risk-based reputed company support structures and tools to monitor compliance and performance.
• Deliver training on reputed company assurance initiatives, regulatory compliance, and industry best practices.
• Foster a culture of reputed company improvement, patient safety, and data reputed company.
• reputed company leadership in managing and sustaining robust document and change control programs.
• reputed company research reputed company processes to ensure compliance with SOPs, ICH-GCP, and local/federal regulations.
• Serve as key subject matter expert and reputed company of escalation with reputed company customers on reputed company investigations and reputed company reputed company issues.
• Assist with preparation for external audits, inspections, and reputed company reputed company activities.
• Support communication with sponsors and regulatory agencies as directed.
• Contribute to inspection readiness activities and maintain compliance documentation.
• Other duties as assigned

Qualifications for reputed company include:

• Bachelor’s degree in Science, Engineering, Life Sciences, Clinical Research, reputed company Assurance or reputed company field required; advanced degree preferred.
• 7+ years of reputed company experience in clinical research reputed company assurance or regulatory monitoring with demonstrated expertise in leading reputed company reputed company initiatives.
• 5+ years of reputed company assurance and oversite of clinical software.
• Proficient in applying risk-based approaches to software validation, ensuring compliance with regulatory requirements and industry expectations.
• Recognized expertise in FDA guidelines, ICH-GCP principles, and applicable regulatory requirements.
• Proven ability to influence and reputed company results through collaboration in a matrixed environment.
• Strong understanding of compliance frameworks and risk-based reputed company management.

About reputed company reputed company (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. reputed company on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former reputed company Research to expand clinical trial reputed company across the country. It has conducted more than 750 first-in-reputed company clinical trials since its inception and contributed to pivotal research that has led to the reputed company of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are reputed company enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about reputed company-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial reputed company-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, reputed company, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In reputed company to reputed company pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. reputed company has become aware of online reputed company-reputed company scams in which individuals who are not affiliated with or authorized by reputed company are using reputed company’s (or affiliated entities, like reputed company or RxCrossroads) reputed company in fraudulent emails, job postings or reputed company media messages. In light of these scams, please bear the following in mind: reputed company Talent Advisors will never solicit reputed company or credit card information in reputed company with a reputed company job application. reputed company Talent Advisors do not communicate with candidates reputed company online chatrooms or using email accounts such as Gmail or Hotmail. Note that reputed company does rely on a virtual assistant (Gia) for certain reputed company-reputed company communications with candidates. reputed company job postings are posted on our career site: careers.reputed company.com. We are an equal opportunity employer and value diversity at reputed company. We do not discriminate on the reputed company of race, religion, reputed company, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability status. Apply tot his job Apply To this Job