Senior CRA
Boston, MA (Hybrid)
$115,000 - $140,000
Job Description
Partnering with a cutting-edge CNS (Central Nervous System) company, EPM is engaged in revolutionizing the landscape of neurological care. This forward-thinking organization, currently in the clinical stage, is dedicated to unraveling the complexities of CNS disorders through groundbreaking research and innovative therapies. With a commitment to pioneering first-in-class treatments, they are shaping the future of neurological healthcare. Join us in a pivotal role where you can contribute to strategies and oversight, ensuring these transformative therapies reach individuals in need. Step into the forefront of CNS innovation and make a lasting impact.
Key Qualifications
- Extensive experience as a Clinical Research Associate (CRA), demonstrating in-depth knowledge of clinical trial processes, protocol adherence, and proficiency in monitoring activities.
- Regulatory Compliance: A solid understanding of regulatory requirements governing clinical trials, ensuring adherence to ethical and legal standards in all aspects of trial conduct.
- Site Management Skills: Proven ability to effectively manage and build relationships with clinical trial sites, ensuring efficient communication, compliance with protocols, and resolution of site-specific issues.
- Data Management Proficiency: Strong skills in data review, source data verification, and query resolution, ensuring the accuracy and integrity of clinical trial data.
- Communication and Collaboration: Excellent communication skills with the ability to collaborate cross-functionally, fostering positive relationships with investigational sites, sponsors, and internal teams to ensure successful trial execution.
Roles and Responsibilities
- Site Management and Monitoring: Oversee and conduct on-site and remote monitoring activities, ensuring that investigational sites adhere to protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Data Quality Assurance: Implement rigorous data review and source data verification processes, identifying discrepancies and ensuring the accuracy, completeness, and integrity of clinical trial data.
- Relationship Building: Cultivate strong relationships with investigational sites, establishing effective communication channels, addressing site-specific needs, and promoting a collaborative environment to optimize site performance.
- Regulatory Compliance: Ensure that all aspects of the clinical trial adhere to regulatory requirements, ethical standards, and company procedures, collaborating with regulatory affairs and addressing any compliance-related issues.
- Risk Mitigation and Issue Resolution: Proactively identify potential risks in the conduct of clinical trials and implement strategic plans for risk mitigation. Address and resolve issues promptly, ensuring the smooth progression of the trial and adherence to timelines.
Benefits
- Medical
- Dental
- 401(k)
- PTO
