Location: United States - Field based
Function: Clinical Operations
The Clinical Trial Educator (CTE), Clinical Operations reports to the Associate Director, Clinical Operations. The CTE is primarily responsible for supporting the successful execution of clinical trials of clinical programs sponsored by Relypsa or its parent company, Vifor Pharma. To this end, the CTE establishes effective and durable relationships with Principal Investigators and investigational staff and ensures a study team presence at the site level. In addition, the CTE collaborates with the in-house study team as well as other internal and external team members in the field to enable timely study milestones and deliverables. The CTE is an ad-hoc member of the global Clinical Study Team (CST).
• Establishes effective and durable relationships with Principal Investigators and investigational site staff participating in studies sponsored by Relypsa and Vifor Pharma to ensure that these studies are placed in high priority at the site level.
• Champions site-specific recruitment plans and strategies. Mitigates barriers to patient recruitment with stakeholders with the goal of accelerating or increasing subject enrollment at each assigned investigational site.
• Educates site on study processes, systems, study protocols and other key documents and eliminates lack of clarity to enable a higher level of study execution by the Principal Investigator and team at the site level.
• Interacts with Principal Investigators and investigational site staff, the Relypsa and Vifor Clinical Study Team (CST), Local Relypsa and Vifor staff for the assigned territory (where applicable) and clinical Service Providers including CRO team members to enable timely, efficient and high-quality deliverables
• Support operational excellence of global clinical trials through vendor oversight activities, including but not limited to accompanied visits, monitoring report review, tracking of trial related metrics and input to respective project plans
• Ensures adherence to ICH GCP, through service provider oversight and interaction with investigational sites, within the assigned country/territory
• Relevant university degree (B.S., M.S. or other) or health care provider degree (RN, PA, NP or other).
• Minimum of 8 years in the pharmaceutical industry or CRO, with current or past experience as a Senior Clinical Research Associate or a Lead CRA role, with direct contact to study sites and KOLs.
• Good understanding of the drug development process and clinical trial execution
• Familiar with clinical trial documentation and regulatory requirements.
• Excellent verbal and written communication and presentation skills.
• Able to interact professionally, productively and persuasively.
• Able to coordinate and multi-task across multiple team functions
• Able to work independently and execute tasks with minimal oversight
• Displays strong organization and time management skills; reliable in completing tasks and delivering on commitments in a timely manner
• Excellent attention to detail
• High ethical standards and integrity
• Fluent in English. Working knowledge of Spanish is preferred. Additional languages are a plus.
• Excellent knowledge of ICH GCP requirements
• Excellent user of Office Programs (Word, Excel, PowerPoint)
• Willingness to travel (65% local and international travel required)
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and stock options reflect Relypsa’s high regard for our employees.
NOTE: This position description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialization of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The Companys first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalemia in more than 50 years. More information is available at www.relypsa.com or check out our LinkedIn page.