Clinical Research Associate
- Job Title
- Clinical Research Associate
- Job ID
- Boulder, CO
- Other Location
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
- 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%
OnKure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancer. Using its proven structure-based drug design approach, the Company is building a robust pipeline of tumor-agnostic candidates that are designed to achieve optimal tolerability and efficacy. OnKure is currently developing its lead clinical candidate, OKI-179, an oral, selective Class I HDAC inhibitor, for the treatment of both hematological and solid tumors.
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.