Emmes Group is a leading clinical research organization dedicated to advancing medical discoveries and improving patient lives. With over 47 years of experience, Emmes has been a trusted partner for US government agencies, public-private partnerships, and biopharmaceutical companies. The company specializes in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.
At Emmes, we foster a collaborative and innovation-driven culture, ensuring that our work directly impacts patient outcomes. Join us in shaping the future of clinical research!
Job Description: Clinical Research Associate II (CRA II)
Primary Purpose
The Clinical Research Associate (CRA) II will be responsible for monitoring clinical trial sites (both on-site and remotely) to ensure compliance with protocols, ICH-GCP guidelines, and regulatory requirements. This role involves conducting site visits, verifying data accuracy, training site staff, and ensuring adherence to study protocols.
Key Responsibilities
✔ Conduct remote and on-site monitoring visits (pre-study, initiation, interim, and close-out visits)
✔ Perform source data verification (SDV), informed consent review, and investigational product (IP) accountability checks
✔ Ensure sites comply with ICH-GCP, SOPs, and regulatory guidelines
✔ Train and retrain site staff on protocols, GCP, and study procedures
✔ Document findings in monitoring visit reports and follow up on action items
✔ Serve as the primary contact for site-related queries and issue resolution
✔ Assist in study document preparation, IRB/EC submissions, and audit readiness
✔ Collaborate with cross-functional teams to meet project timelines
Qualifications & Skills
✔ Bachelor’s degree (preferably in Life Sciences or related field)
✔ 1-2 years of monitoring experience (on-site & remote)
✔ Strong knowledge of ICH-GCP, clinical trial regulations, and site management
✔ Proficient in MS Office (Word, Excel, PowerPoint)
✔ Excellent communication, organizational, and problem-solving skills
✔ Ability to work independently and in a team with minimal supervision
✔ Attention to detail and ability to manage multiple projects
Why Join Emmes Group?
✅ Work on cutting-edge clinical trials in gene therapy, vaccines, and rare diseases
✅ Flexible remote & hybrid work options
✅ Career growth opportunities in a globally recognized CRO
✅ Collaborative and impact-driven work culture
