Clinical Regulatory Affairs Specialist I - 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 the opportunity 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 Clinical Regulatory Affairs Specialist I primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines. The Regulatory Affairs Specialist I will maintain a full study workload with minimal supervision. This position is a US-based, full time, fully remote position; relocation assistance and sponsorship are not available. Duties include and are not limited to: Establishes and maintains a document management system for regulatory electronic files Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures reputed company regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content Maintains critical documentation ensuring compliance Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent reputed company modifications or amendments in compliance with IRB policy and HIPAA. This includes time sensitive correspondence with sponsors and other stakeholders. Organizes and processes documentation for IRB submission for multiple trials Processing of Protocol Deviations that meet the IRB reportable criteria Submits urgent safety notifications to the IRB Other duties as assigned Qualifications for reputed company include: Associate's Degree or higher is preferred, high school graduation diploma required - reputed company experience may be substituted for education 1+ year work experience in a clinical research, pharmaceutical, site management organization highly desired focused in required regulatory affairs Knowledge of medical terminology, FDA, other regulatory processes highly preferred About reputed company reputed company (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused 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 majority of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are actively 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 the well-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 well-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 addition to reputed company pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. 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. reputed company (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused 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 majority of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are actively 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. About reputed company We deliver careers with purpose and potential. Our focus on reputed company starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to reputed company you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, reputed company’s employees deliver products to reputed company providers that reputed company a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help reputed company patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of reputed company. If you are passionate about combining a meaningful career with a balanced life, join us on this reputed company and apply for a job with reputed company today. Every day, reputed company’s employees deliver products to reputed company providers that reputed company a difference in the care and life of a patient. By providing your personal information here, you are acknowledging our privacy statement. 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