Lancesoft

Compensation

Full Description

Job Description : The Clinical Research Associate (Monitor) is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required. Responsibilities : • Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits and site initiation visits to ensure applicability of sites for planned study according to application regulatory requirements. • Collaborate with Senior Clinical Research Associate to create source documentation / CRFs in alignment with protocol requirements. • Collaborate with sites and internal stakeholders to align and implement site specific language for each consent / assent and support Institutional Review Board (IRB) submissions. • Train site staff on protocol requirements, source documentation, and case report form completion. • Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted. • Conduct clinical study site close-out visits and ensure site files are complete, accurate and up to date. • File site related documents real-time to ensure Trial Master Files are complete and accurate at all times. • Provide study specific information and support report validation activities as requested for clinical study reports. • Participates in team meetings and document meeting minutes and tracks action items. • Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines. • Performs other duties as required (note, all listed tasks may not be conducted depending on study status and roles of other internal and external team members). Education and Experience : • B.S. Or B.A. And / or an equivalent combination of education or experience. • Minimum of 3 years of experience directly related to the execution of clinical research studies. • Available to travel (up to 60%) on short notice and independently manage travel schedules. • Must have analytical skills, be detail oriented and have good interpersonal skills. • Knowledge of agency guidelines and requirements. Skills / Competencies : • Effective written and verbal communication skills. • Ability to communicate at all levels of an organization. • PC skills;word processing, spreadsheet, database, Internet search and utilization. • Flexible and able to work in a fast-paced environment. • Team player. • Ability to organize and judge priorities. • Excellent ability to generate and maintain accurate records. Start Date - End Date : Jan 5 –Oct 3, 2026