Clinical Research Associate
We are currently seeking a qualified, highly motivated, Clinical Research Associate (CRA) to join our team supporting management of Tricida-sponsored clinical trials. This position will report to the Vice President, Clinical Operations. The primary focus of this in-house CRA position is working with Contract Research Organizations (CROs) and other Contract Service Providers (CSPs) to ensure conduct of Tricida clinical trials in compliance with ICH GCP Guidelines and attainment of overall clinical study objectives.
We can offer:
- The chance to join a successful and growing organization with an unmatched leadership team, passionate about their employees.
- An opportunity to make a real impact on chronic kidney disease patients with our cutting-edge therapeutics.
- A supportive, collaborative work environment, with colleagues who care about the success of the organization.
- A place that will treat you fairly, provide competitive compensation, on-going recognition, and most of all, a chance to learn, contribute and develop your skills.
- Fun, enthusiasm, support, a passion for healthy living and never a dull moment…
- Develop tracking tools and processes to increase measured efficiencies of the clinical study.
- Help in review and development of study-related documents including but not limited to: study protocols, Informed Consent Forms and other patient-facing materials, CRFs, various study plans, manuals, instructions, etc.
- Review CRO-prepared monitoring visit reports, ensuring that all identified issues are being tracked to resolution.
- Participate in co-monitoring with CRO's CRAs as needed.
- Ensure appropriate documentation of all identified site- and protocol-related issues.
- Partner with and support CRO, ensuring TMF is complete and appropriately maintained.
- Assist in site selection, study implementation and ongoing management either directly or via CSPs.
- Partner with other departments within Tricida (Regulatory, Legal, CMC, etc.) and consultants ensuring that Tricida-sponsored clinical trials are conducted in accordance with corporate SOPs, GCP and ICH Guidelines and applicable federal and local regulations.
- Coordinate and participate in Investigators’ Meetings.
- Travel will comprise up to 10%.
Experience & Skills:
- Bachelor’s degree in science, nursing, or equivalent with minimum of 2 years of CRA experience.
- In-depth working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Familiarity with pharmaceutical and medical terminology.
- Must be able to multi-task and execute in a fast-paced, changing environment, with adherence to timelines.
- Excellent communication skills and the ability to work well within a multi-disciplinary team.
- Proactive, assertive, and creative problem-solver.
- Attention to detail and meticulous follow-through, with strong organizational skills.
- Experience with EDC platforms.
- Microsoft Office Suite proficiency (Word, Excel, PowerPoint).
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday will also be provided according to company practice.
Tricida is located in South San Francisco, CA. This is an on-site position