Job Summary
The Senior Clinical Research Associate specializing in Breast Oncology plays a crucial role in overseeing clinical trials. This position demands a comprehensive understanding of clinical research processes and the ability to ensure compliance with regulatory standards. The Associate will collaborate with various stakeholders to facilitate the execution and management of breast specialty trials, contributing significantly to advancing cancer research.
Responsibilities
- Oversee the planning, coordination, and execution of clinical trials within the breast cancer specialty area.
- Ensure compliance with ethical standards, regulatory requirements, and protocols throughout the research process.
- Act as a primary contact between clinical sites and the sponsor, providing guidance and support as needed.
- Monitor trial progress, including patient recruitment, data collection, and site management.
- Conduct site visits to assess compliance, resolve issues, and provide training to site personnel.
- Prepare and review study documentation, reports, and deliverables necessary for trial progress.
- Collaborate with cross-functional teams to contribute to the development of clinical strategy and trial design.
Qualifications
- Bachelor’s degree in a related field, with advanced degrees preferred.
- Proven experience as a Clinical Research Associate, especially in oncology or breast specialty trials.
- Strong knowledge of Good Clinical Practices (GCP) and regulatory requirements.
- Excellent organizational, analytical, and communication skills.
- Ability to work independently and manage multiple tasks effectively.
AxoGen provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
