Participate in planning and direction of clinical research studies supporting development of therapeutics for treatment of disease; Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits. Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits. Manage the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment, and enrolment, CRF completion and submission, and data query generation and resolution; Conduct research to develop methodologies and procedures for data analysis and presentation of clinical research findings; Provide project updates to project management team; Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites; Perform investigational product inventory, ensuring return of unused investigational product to designated location or verifies destruction as required; Assists with, and attends, Investigator Meetings for assigned studies; Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate Issues at site to project management; Adhere to strict safety procedures regarding chemicals and materials used in clinical research process; Collect and review essential study documents from site for filing in eTMF; Administer protocol and study related training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues; Evaluate quality and integrity of study site practices related to the proper study conduct, ensuring adherence to applicable regulations; Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participate in the planning of quality assurance activities and coordinates resolution of audit findings; To lead and partake in regular team meeting / teleconferences regarding clinical study management and progress; Assist, as appropriate, with reporting site performance regarding timelines and deliverables to the project team during team meetings and assist with providing feedback for analysis of overall study performance. Telecommuting is permissible.
Requires bachelor's degree in Clinical Research, Biomedical Science, Biotechnology or closely related field. Degree equivalent based on any suitable combination of foreign education, experience, and training acceptable. Requires one year of experience in job offered.
To apply, submit resume to [email protected]
Pay: From $103,000.00 per year
Work Location: Hybrid remote in Aventura, FL 33180
