Senior Clinical Research Associate (CRA) - Oncology Biotech
Location: Remote (US-based)
About Us:
We are a passionate team dedicated to advancing transformative therapies to improve the lives of patients with cancer and other serious diseases. By harnessing cutting-edge science and innovative approaches, we are committed to bringing new hope to patients and their families.
As part of our dynamic and growing team, you will play a pivotal role in driving clinical research that translates into meaningful medical advancements.
Position Overview:
This Oncology Biotech is seeking a Senior Clinical Research Associate (CRA) to lead and manage clinical trials focused on oncology and immune-mediated therapies. This position offers an exciting opportunity to contribute to the successful execution of our clinical programs and work collaboratively with cross-functional teams in a fast-paced environment.
Key Responsibilities:
- Oversee the implementation and execution of assigned clinical trials, ensuring compliance with protocols, regulatory guidelines, and company SOPs.
- Conduct site selection, initiation, monitoring, and close-out visits across multiple study sites.
- Provide training and support to site personnel to ensure study compliance and quality data collection.
- Monitor site performance, resolve issues, and proactively address risks to meet timelines and objectives.
- Collaborate with internal teams (e.g., Clinical Operations, Data Management, and Medical Affairs) to support trial execution and resolve operational challenges.
- Review site documents for accuracy, completeness, and compliance with regulatory requirements.
- Ensure accurate and timely reporting of monitoring activities and findings in line with study documentation requirements.
- Contribute to protocol development, study manuals, and monitoring plans.
- Maintain up-to-date knowledge of industry trends, regulatory requirements, and therapeutic advancements relevant to the clinical focus areas.
Qualifications:
- Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
- Minimum of 5 years of CRA experience in the pharmaceutical or biotechnology industry, with at least 2 years in a senior role.
- Oncology experience is strongly preferred.
- Comprehensive understanding of GCP, ICH guidelines, and regulatory requirements.
- Excellent problem-solving, organizational, and communication skills.
- Ability to manage multiple priorities and thrive in a dynamic environment.
- Proficient in electronic data capture (EDC) systems and other clinical trial management tools.
- Willingness to travel (up to 25%) to study sites as required.
Why Join Us?
- Be part of a mission-driven company making a meaningful impact in the lives of patients.
- Collaborate with a talented, diverse team in a supportive and innovative environment.
- Competitive salary and comprehensive benefits package, including stock options, health insurance, and generous PTO.
If you're passionate about advancing oncology research and looking to grow your career in a cutting-edge organization, we'd love to hear from you.