Chinook Therapeutics

Clinical Trial Associate

Clinical Ops (600) - Remote, Washington

Company:

Chronic kidney diseases are a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation, and high costs to health care systems. Up to 10% of the global population suffers from kidney disease and in the U.S. alone, kidney diseases account for over $130 billion in annual costs.

At Chinook Therapeutics our purpose is to discover and develop precision therapies to preserve kidney function and make dialysis and transplant unnecessary for people living with kidney disease. We strive for excellence in all we do and think big in our innovation; our highest priority is to do the right thing for patients while working together and having a whole lot of fun!

Our pipeline of precision medicines targets rare, severe kidney disorders with few currently approved therapies. For more information on Chinook and our pipeline, check out our site www.chinooktx.com/about & www.chinooktx.com/pipeline. We trade on Nasdaq under the ticker symbol KDNY and are headquartered in Seattle, WA with offices in Vancouver, BC, and Oakland, CA.

We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce –come and be a part of our growth.

At Chinook, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate is not exactly as we describe it here.

Position:

As a vital member of Chinook's Clinical Operations team, the Clinical Trial Associate (CTA) will assist in the execution of clinical trials. The CTA role will provide day-to-day operational support including maintaining the Trial Master File (TMF) and Clinical Management System (CTMS). Reporting to the Manager, Clinical Trial Associates or above.

Responsibilities include:

• Support development and maintenance of clinical study tracking tools and files.
• Monitor and track the status of study-related activities and deliverables to help ensure timely completion and provide regular status updates to study teams.
• Assist with preparation and distribution of written materials, e.g., site training materials, study manuals and plans, presentations, etc.
• Maintain CTMS and TMF.
• Conduct periodic TMF Health reviews and follow findings to closure.
• Contribute to TMF inspection-readiness activities.
• Coordinate, schedule and support various meetings, including agendas, minutes, and updates to decision and action logs as needed.
• Support patient recruitment and retention.
• Assist with clinical data review Assist with Essential Regulatory Document review.
• Support clinical site management activities as assigned.
• Support vendor management activities as assigned.
• Support implementation, maintenance, and administration of clinical systems.
• Support site, CRO, and internal requests for access to vendor systems.
• Bridge work between Clinical Study Operations and Finance to support timely execution of contracts and payments.
• Assist in the management of study budgets, reconciliation of invoices, liaise with Finance and Contracts teams.
• Ensure activities are conducted in compliance with Chinook SOPs and applicable regulations.
• Actively learn and increase understanding and awareness related to drug development, clinical trials, related regulations, study indications, scientific understanding, and trial related technology solutions.
• Perform other administrative duties as assigned.
• Contribute to the development and maintenance of a positive team-focused company culture.

Location:

Chinook has offices located in Seattle WA, Oakland CA, and Vancouver BC

• This position may be located at any Chinook office location or remote (within US or Canada)

Education, Experience, and Skills:

Required

• Undergraduate degree or equivalent experience and education.
• At least 2 years prior work experience, preferably in a biotech, pharmaceutical, health, science, or business-related field.

Preferred:

• Prior CTA, Clinical Research Coordinator, Clinical Data Coordinator experience strongly preferred.
• Basic knowledge and understanding of research regulatory guidelines and policies, i.e., GCP/ICH, the Code of Federal Regulation.
• Excellent written/verbal communication skills.
• Detail oriented and organized.
• Proficiency with Microsoft Office Products (Word, Excel, Outlook, PowerPoint, SharePoint) and other electronic systems (CTMS and eTMF) as well as virtual meeting technologies such as Zoom and Teams.

Salary Range: $37.92 - $44.23 (hourly)

Benefits:

• Paid parental leave
• Vacation and Sick time
• Living organ donor leave
• Volunteer time off
• 15 Paid Holidays
• Hybrid Work
• Flexible scheduling
• Healthcare plans
• Retirement Matching
• Financial wellness programs
• Employee assistance programs (EAPs)
• Internal learning & development courses

Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We respect and value different experiences and viewpoints. We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

To Apply:

Chinook Therapeutics

Chinook Therapeutics is an Equal Opportunity Employer

Submitted: 01/25/2023