CRO-Clinical Monitoring Support Associate (Remote)

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.