About Company
Lotus Clinical Research, LLC is differentiated from other CROs by our common ownership with Evolution Research Group (ERG). Our highly sought-after, US-based sites include 20 wholly-owned research units, over 400 beds, nine surgical centers, and multiple Phase 1 units, providing access to specialized capabilities for both healthy volunteer studies and targeted patient populations in neuroscience and metabolic disease research.
This unique Lotus-ERG structure enables rapid study startup and unparalleled operational efficiency, as many of the slow-track activities associated with site initiation (contracting, legal, etc.) are already in place. The leadership, medical, and operational teams are in constant communication and Lotus-Sponsored studies are prioritized.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
About the Role
- The CRO-Clinical Monitoring Support Associate (Remote) plays a critical role in supporting clinical trial operations to ensure the integrity, accuracy, and compliance of clinical data collected during studies.
- This position involves collaborating closely with clinical monitors, project managers, and other stakeholders to facilitate smooth trial execution and adherence to regulatory standards.
- The associate will be responsible for managing and organizing clinical trial documentation, tracking study progress, and assisting in the resolution of data queries.
- By providing timely and accurate support, this role helps to maintain high-quality data and supports the overall success of clinical research projects.
- Ultimately, the position contributes to advancing healthcare by ensuring that clinical trials are conducted efficiently and ethically within the United States healthcare framework.
Minimum Qualifications
- Bachelor’s degree in life sciences, health sciences, or a related field.
- Basic understanding of clinical research processes and Good Clinical Practice (GCP) guidelines.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and clinical trial management systems.
- Strong organizational skills with attention to detail and ability to manage multiple tasks simultaneously.
- Excellent written and verbal communication skills in English.
Preferred Qualifications
- Experience working in a clinical research organization (CRO) or healthcare setting.
- Familiarity with electronic data capture (EDC) systems and clinical trial management software.
- Certification in clinical research (e.g., CCRC, CCRA) or related credentials.
- Knowledge of regulatory requirements specific to clinical trials conducted in the United States.
- Ability to work collaboratively in a team environment and adapt to changing project needs.
Responsibilities
- Assist clinical monitors in the preparation and maintenance of essential trial documentation and regulatory binders.
- Track and report on clinical trial progress, including patient enrollment, data collection status, and site compliance.
- Support the resolution of data queries by liaising between clinical sites and data management teams.
- Coordinate communication among clinical trial sites, monitors, and internal teams to ensure timely information flow.
- Maintain accurate records of monitoring visits, follow-up actions, and study correspondence in compliance with SOPs and regulatory requirements.
Skills
- The required skills enable the associate to efficiently manage and organize clinical trial documentation, ensuring compliance with regulatory standards and facilitating smooth communication among stakeholders.
- Proficiency in Microsoft Office and clinical trial management systems supports accurate tracking and reporting of study progress.
- Strong organizational and multitasking abilities allow the associate to handle various responsibilities simultaneously without compromising quality.
- Effective communication skills are essential for coordinating between clinical sites, monitors, and internal teams to resolve data queries and maintain study timelines.
- Preferred skills such as familiarity with EDC systems and clinical research certifications enhance the associate’s capability to contribute more independently and with greater technical expertise to the clinical monitoring process.
