Emmes Group is on a mission to transform the landscape of clinical research, making innovative medical discoveries accessible to patients worldwide. Founded over 47 years ago, Emmes has built a solid reputation as a leading clinical research provider, initially serving government entities and expanding into partnerships with commercial biopharma companies. Emmes Group specializes in various domains including cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. The organization is driven by a collaborative culture that values both performance and people, making it an ideal workplace for those passionate about advancing clinical research.
Responsibilities in Job
As a Clinical Research Associate II (CRA II) at Emmes Group, you will be an integral part of the clinical research process. Here are your primary responsibilities:
- Site Monitoring: Conduct both remote and on-site monitoring visits, including qualification/pre-study visits, site initiation visits, routine checks, and closeout visits.
- Informed Consent Review: Independently review Informed Consent Forms (ICF) and ensure compliance with regulatory standards.
- Source Data Verification: Review and verify source documents, laboratory assessments, and Investigational Product (IP) storage conditions.
- Documentation: Document all monitoring activities in site visit reports, facilitating action item resolution and communicating issues to project leads.
- Training and Support: Provide training and retraining to site staff on protocols, good clinical practices (GCP), and other relevant topics.
- Project Collaboration: Work closely with project teams, attend meetings, and report on site-specific performance to manage clinical study progression effectively.
- Audit Preparation: Assist in site audits and ensure that all operations comply with regulatory requirements and internal SOPs.
Qualifications
To qualify for the CRA II position at Emmes, candidates should meet the following criteria:
- Education: A bachelor’s degree in a scientific discipline or equivalent work experience.
- Experience: A minimum of 1-2 years of relevant monitoring experience, both on-site and remote.
- Technical Skills: Proficient in MS Office Suite with excellent organizational and computer skills.
Skills
Emmes Group seeks candidates who exhibit the following skills:
- Attention to Detail: A keen eye for detail is essential to ensure compliance and performance in clinical trials.
- Critical Thinking: Ability to assess situations and make informed decisions in a dynamic environment.
- Communication: Excellent interpersonal and written communication skills for effective collaboration.
- Problem-Solving: Demonstrated capability to identify issues and implement effective solutions.
- Teamwork: Ability to work cross-functionally and collaboratively within project teams.
