Chinook Therapeutics

Sr. Site Activation Specialist

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 Development Operations team, the Sr. Site Activation Specialist will play a key role within the Clinical Business Operations team in the execution of clinical trials. The role will provide day-to-day operational expertise and guidance relating to Informed Consent Form (ICF) requirements and activities as well as site regulatory document needs during start-up and throughout the life of the studies. Reporting to the Associate Director, Clinical Process Management or above.

Responsibilities include:

• Collaborate internally and externally on the development of ICFs and other patient-facing documents
• Independent review and approval of country ICF templates
• Independent review and approval of site-specific ICFs
• Independent review and approval of site Essential Regulatory Pack (ERP) documents to enable site activation and study drug shipment
• Manage information and workflows related to ICFs and ERPs within the Clinical Trial Management System (CTMS)
• Participate in inspection-readiness activities
• Assist with preparation and follow up of internal process audits and regulatory authority inspections as required
• Support management of relevant vendor activities as assigned
• Contribute to the development and maintenance of processes and work instructions
• Mentor and coach junior or new team members
• Ensure activities are conducted in compliance with Chinook SOPs and applicable regulations
• Actively learn and continue to increase understanding and awareness related to drug development, clinical trials, related regulations, study indications, scientific understanding, and trial related technology solutions
• Support Clinical Business Operations initiatives as assigned
• Participate in 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

• Bachelor's degree or equivalent, preferably in a health or science-related field
• At least 5 years prior work experience, preferably in a biotech, pharmaceutical, health, science, finance, or business-related field
• Prior experience with independent approval of site documents
• Prior experience with ICF development
• Expert knowledge and understanding of CFR, GCP/ICH, and HIPAA requirements

Preferred:

• Critical thinking, decision-making, and leadership skills
• Highly organized and proactive Approachable and responsive
• Excellent written/verbal communication skills
• Energized by challenges

Salary Range: $116,000 - $135,000

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: 01/21/2023