Join Our Team - OnKure, Inc.
 
people in a business meeting
Careers

We are building a skilled and dedicated team of experienced life science leaders who are driven by our common mission: to develop differentiated therapies to improve the lives of patients. We work with a sense of urgency and purpose, foster a collaborative culture that prioritizes cross-functional learning and reward our employees with highly competitive benefits.

Located in Boulder, Colorado, which was recently awarded the best place to live by U.S. News, OnKure is actively seeking to hire ambitious team players to expand our growing organization.

Location

Clinical Research Associate

Job Title
Clinical Research Associate
Job ID
27652002
Location
Boulder,  CO
Other Location
Description
OnKure is looking for an in-house CRA to join their team and contribute to driving forward the development of a robust pipeline of oncology drug candidates.

What you will Achieve:
You will provide support in the overall management of clinical trials. Study management tasks will be performed in collaboration with the study lead with an emphasis on ensuring CROs and other vendors are performing per expectations. Tracking, findings, and solutions will be communicated to the study lead and wider team.
​​​​​​

How you will Achieve It:
  • Act as a support to the study lead in working with stakeholders and cross-functional teams; provide updates to the clinical study team as appropriate
  • Act as a point of contact for the CRO and vendors; develop and maintain productive relationships
  • Work closely with the study lead to hold external partners (e.g., Contract Research Organizations and vendors) accountable to deliverables 
  • Maintain meeting minutes and track study metrics related to sponsor oversight
  • Track study supplies and coordinate shipments of supplies to sites as needed
  • Assist in the development of study plans and status reports
  • As requested, provide support with data review, data queries, etc.
  • Assist with development and review of informed consent forms
  • Supports TMF processes and maintenance as well as final reconciliation of study documents
  • Assist with onsite monitoring activities including co-monitoring or sponsor oversight visits
  • Contribute to review of site monitoring reports. Identifying any site and/or CRA performance issues, quality events or any other quality issues at the patient and/or site level and escalate to the study lead.
  • Identify site risks and ensure appropriate escalation and accurate and timely communication. Assist with Corrective actions and preventive actions if needed.
  • Participate and perform other related duties as required to support Clinical Operations
  • Think strategically, work agilely and independently in a dynamic and evolving environment
  • Bring a critical thinking/problem solving mind set
Preferred Experience and Qualifications:
  • BS/BA or higher degree required (life sciences preferred) with at least 3 years of experience in clinical trial research
  • Solid knowledge of clinical development processes with an ability to understand complex protocol processes and procedures
  • Oncology clinical trial experience preferred
  • Must have a thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
  • Proficiency with Microsoft Programs, electronic data capture systems, and trial management tools
  • Attention to detail, excellent written and verbal communication skills
  • Ability to prioritize and manage multiple tasks simultaneously, identify and resolve issues, and effectively manage timelines.
  • Travel up to 20%
About OnKure:
OnKure, Inc. is a private biotech company, based in Boulder, Colorado. The company was founded and is led by several scientific leaders from Array BioPharma, another Boulder-based company. Our mission is to create novel, high quality drugs to provide meaningful therapy for cancer patients. Our near-term goals are to advance our clinical stage drug, OKI-179, into several Phase 2 clinical trials, build a state-of-the-art drug discovery group and establish a robust pipeline of projects and development candidates.

Our Boulder facilities feature modern offices, and new laboratories are under construction.  With the mountains at our doorstep, great schools, cultural and unparalleled outdoor activities, Boulder is the No. 1 place to live out of the 150 most populous metro areas in the U.S. for the second year in a row! 

To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability), self-managed paid time off, and a 401(k) plan with company match. We operate on a flexible schedule that allows a combination of both in-office and home-based work.

Annual compensation range for this role, based on experience is $60,000-$90,000.

OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected factors.​​

Option 1: Create a New Profile