Regional Monitor - Florida/Atlanta

Clinical Research Associate (CRA) needed in Florida or Atlanta, GA!

Two years monitoring experience required; Bachelors degree required; neuroscience experience preferred



Responsibilities:

The Clinical Research Associate (CRA) is responsible for facilitating the clinical investigator selection process, managing patient enrollment and overseeing the clinical trial process utilizing fundamental principles of monitoring at the study site from site selection to closeout. Identify, evaluate and qualify potential investigators. Accountable for site-specific enrollment. Identifies, defines, coordinates and conducts site study training. Clinical report forms (CRF) are source data verified or reviewed according to the monitoring plan. Manage CRF backlog and facilitate query resolution. Drug accountability is complete and accurate. Compliance to Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, U.S. Food and Drug Administration (FDA) regulations, applicable policies and procedures, and Principles of Medical Research. Generates and distributes monitoring visit reports. Conducts site closeout and assures appropriate archival of regulatory documents. Maintains inspection readiness at the site level. Serves as primary point of contact for site personnel regarding study or process-related issues. Ensures proper escalation of site-related issues according to global and local procedures. Ensures site level metrics are tracked (IMPACT) and communicated as appropriate. Maintain corporate asset protection at all times. Effectively uses communication tools (e.g., email, voicemail, collaboration databases). Maintains timely interaction with internal and external customers. Timely completion of all administrative tasks (e.g. calendaring, expense reports, time entry, training). Accountable for meeting monitoring timelines and metrics including CRF and query cycle time. Enrollment. Last CRF in house commitments for datalocks.  Candidates must live in Florida or Atlanta. 

Requirements:

Candidates must have at least 2 years of monitoring and a Bachelor's degree preferably in a project management, health-related or scientific field.  Directly related clinical trial experience or relevant clinical development experience preferred; Knowledge of GCPs, FDA regulations and ICH guidelines; Strong leadership, interpersonal skills and influence; Excellent oral and written communication skills. Demonstrate ability to articulate issues; Strong problem-solving skills; Excellent self-management and organizational skills; Detail oriented; Computer skills (e.g., Excel, Word, PowerPoint)