Careers
Senior Clinical Research Associate
Location: United States - Field based 
Division: Clinical
Company: Vifor Pharma
About You
Responsibilities:
We are currently looking for a Senior Clinical Research Associate to support our Clinical Operations Team. Reporting to the Director, Clinical Operations, you will be part of a cross-functional team and contribute to the operational execution of global clinical trials, as well as support the performance and quality targets for Vifor Pharma-sponsored studies.
You bring excellent verbal and written communication skills. Your attitude and entrepreneurial spirit are congruent with the company values. You are interpersonally aware and culturally sensitive, with the ability to work in highly networked organizations with many partners. You are a team player, working well in cross-functional teams, but also being able to work independently. You take a thorough approach with high attention to detail and can think and influence conceptually, strategically and rationally. You are effectively able to plan and prioritize workload, with an accurate sense of urgency. You are an eager learner and can act as a fast-paced, proactive ambassador of Vifor Pharma.
Tasks:
‒ Provide project-specific support and conduct site visits to oversee the activities of the CRAs and the contracted CRO
‒ Ensure proper adherence to global and local clinical research regulations
‒ Support the study sites to reach Vifor Pharma’s targets regarding patient recruitment, data quality and timelines
‒ Participate in development of project-specific documents (protocol, ICF), plans (e.g., Clinical Monitoring, Communication, Project Management, etc.), and other study-related documents (manuals, instructions, etc.)
‒ Support study site selection process
‒ Manage external vendors that provide systems supporting clinical trial conduct (e.g., CTMS, EDC, IWRS, eTMF, etc.)
‒ Prepare internal and external memos, reports, documents, and correspondence required to properly manage and document activities on clinical studies
‒ Assist study sites in query resolution
‒ Coordinate the collection and management of clinical trial documentation to be filed in Trial Master File and Electronic Study Files
‒ Support operational execution of clinical trials, from start-up activities until study close-out
‒ Ensure operational support of clinical study teams including taking and distributing meeting minutes and follow up action items
‒ Set-up, manage and maintain ICH GCP compliant Trial Master File and assist in review and audit of vendor Trial Master File to ensure compliance
‒ Provide input into department SOPs and procedures
‒ Be an active member of internal and external clinical study teams
Qualifications:
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:
Minimum Requirements
‒ Bachelor’s degree in Life Sciences or equivalent degree
‒ 5+ years of experience in the pharmaceutical industry, including relevant experience as Clinical Research Associate, including on-site monitoring and oversight of CROs/vendors
‒ Strong working knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing of the conduct of clinical trials
‒ Familiar with clinical trial documentation and regulatory requirements
‒ Proficiency in Microsoft Applications (Word, Excel, PowerPoint)
‒ Fluency in English, oral and written
‒ Ability to travel (up to 40%)
Preferred Requirements
- Advanced (graduate) degree is preferred
- Experience in nephrology and/or working with dialysis units is a plus
- Experience in rare disease is a plus
- Additional language skills are a plus (e.g., Spanish)
PLEASE NOTE:
As a federal contractor, Vifor Pharma, Inc. is required to comply with Executive Order 14042, which requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason, a genuine religious belief, on an individual basis in accordance with applicable legal requirements. All employees must be in compliance with Vifor Pharma, Inc.’s COVID-19 vaccine policy at the commencement of their employment.
About Us
At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day.
Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career.
What you can expect of us
As we work to support patients, we also take care for our employees’ professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.
Including:
- Open, safe and inclusive culture that fosters creativity and unleashes individual potential, whether in laboratories, manufacturing sites, in the field, or offices
- Learning opportunities that enhances your skill set focused on business and personal effectiveness, leadership and management skills, and much more
- Flexible workplace environment, home office opportunities, competitive vacation entitlement
- Attractive financial participation schemes, adapted regionally, that provide employees with additional security for every life situation, including: Pension plans, participation schemes, and savings plans
Join Vifor Pharma Talent Community
If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community.