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Clinical Trial Assistant

LensaDurham, NC
yesterday
Hybrid

Company

Lensa

Location

Durham, NC

Work Schedule

full time

Work Location

hybrid

Job Description

Lensa in Durham, NC seeks a Clinical Trial Assistant to support biotech clinical trials. Responsibilities include data management, documentation, and coordination with teams to ensure trial compliance and success.

Full Description

Job Overview: Lensa, a leading player in the biotech-pharmaceutical sector, is seeking a dedicated Clinical Trial Assistant to join our dynamic team in Durham, North Carolina. This role is pivotal in supporting the execution of clinical trials, ensuring seamless operations from initiation to completion, and contributing to groundbreaking advancements in pharmaceutical research. Key Responsibilities: Assist in the preparation and maintenance of clinical trial documentation, including protocols, informed consent forms, and case report forms. Coordinate scheduling of trial-related activities, such as participant visits, investigator meetings, and monitoring visits. Manage trial supplies inventory, ensuring adequate stock of investigational products and materials. Collect, process, and enter clinical data into electronic data capture systems while maintaining accuracy and confidentiality. Liaise with internal teams, external vendors, and clinical sites to facilitate smooth communication and resolve issues promptly. Support regulatory submissions by compiling necessary documents and tracking compliance with FDA and ICH-GCP guidelines. Monitor trial progress through metrics and reports, flagging any deviations or risks to the project manager. Participate in trial close-out activities, including data reconciliation and archive preparation. Required Qualifications: Bachelor's degree in life sciences, nursing, or a related field. At least 1-2 years of experience in clinical research, preferably in a trial support role. Familiarity with clinical trial processes and Good Clinical Practice (GCP) standards. Proficiency in Microsoft Office Suite, particularly Excel for data management. Skills: Strong organizational and multitasking abilities to handle multiple trials simultaneously. Excellent attention to detail for accurate data handling and documentation. Effective communication skills, both written and verbal, for interacting with diverse stakeholders. Problem-solving mindset to address operational challenges efficiently. Basic knowledge of clinical trial management systems (e.g., EDC, CTMS) is a plus. Ability to work independently and collaboratively in a fast-paced environment. Company Info: Lensa is at the forefront of biotech innovation in Durham, NC, a hub for pharmaceutical research. We foster a collaborative culture focused on employee development and cutting-edge science to bring life-changing therapies to market. Benefits: Competitive salary package with comprehensive health, dental, and vision insurance. Generous 401(k) matching, paid time off, and flexible spending accounts. Professional development opportunities including tuition reimbursement and conference attendance. Growth Opportunities: Advance your career within clinical operations, from assistant to coordinator or manager roles. Access mentorship programs, cross-functional projects, and leadership training to build expertise in biotech R&D.

Key Skills

Clinical Trial ManagementData Entry and AccuracyGCP ComplianceRegulatory DocumentationStakeholder Coordination