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Detailed Description

Job Summary: The Clinical Research Associate is responsible for clinical monitoring for assigned protocols and investigational sites. The Clinical Research Associate reports to the Monitoring Manager or designee and is responsible for ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP) and other applicable regulatory requirements.

Essential Functions:

· Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote. This includes evaluation, site initiation, interim and close out monitoring visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters.

· Supports development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guideline, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements.

· Responsible for source document and case report forms review for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.

· Managing, preparing, sending, tracking, and returning investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliation.

· Monitoring assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements.

· Responsible for review and oversight of regulatory documentations for accuracy, completeness, and supporting assigned clinical sites with any regulatory concerns as appropriate.

· Responsible for consistent and timely communication with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinical

trials to address any study needs related to the monitoring and site management activities as assigned.

· Participates in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial.

Necessary Skills and Abilities:

· Excellent verbal, written communication skills and interpersonal and presentation skills are required. · Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required.

· Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required.

· Knowledge of applicable regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.

· Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.

· Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals.

· Must have a general understanding of routine project goals from an organizational perspective.

· Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential.

Educational Requirements:

· Bachelor's degree or equivalent combination of education and experience.

Experience Requirements:

· 0-3 years of experience as a Clinical Research Associate