Clinical Research Regulatory Affairs Specialist II - Remote US

It’s More Than a Career, It’s a Mission.

Our people are the foundation of our success. 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 outcomes 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 excellence and cutting-edge research, SCRI is redefining cancer care around the world.

Our Clinical Regulatory Affairs Specialist II 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 form 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 success include:

• Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education

• 3+ years' regulatory affairs work experience in a clinical research, pharmaceutical, site management organization highly desired

• 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 access across the country. It has conducted more than 750 first-in-human 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.

reputed company has become aware of online recruiting-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) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: reputed company Talent Advisors will never solicit money 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 recruiting-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 our company. We do not discriminate on the basis of race, religion, color, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability status.