Regulatory Affairs Specialist
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.
Job reputed company
Our Clinical Regulatory Affairs Specialist 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 reputed company 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 reputed company
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 reputed company 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. 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 850 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 in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ 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.
Originally posted on Himalayas
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