Senior CRA
Philadelphia, PA (Hybrid)
$115,000 - $135,000
Job Description
EPM is partnered with a cutting-edge biopharmaceutical firm with a focus on creating small-molecule and protein treatments for both orphan and high-value indications that target cancer, immune disorders, and inflammatory illnesses. They are utilizing cutting edge science and technology to alter the future of healthcare and the lives of their patients by merging AI-driven diagnostics to personalize patient data. To handle their products while they are still in the clinical stages and assist with vendor interactions, they are looking to hire a CTM/Senior CTM. To guarantee that clinical studies are carried out on schedule, you will collaborate cross-functionally with internal team members, vendors, and clinical study sites.
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
