Note: The job is a remote job and is open to candidates in USA. ProPharma is a clinical research organization, and they are seeking a Senior Clinical Research Associate to oversee and conduct monitoring visits for clinical trials. The role involves managing site activities, ensuring compliance with regulatory requirements, and supporting study documentation development.
Responsibilities
- 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
- Ex-US: May be responsible for performing study start up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities
- Support development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, 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
- Review source document and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
- Manage, prepare, send, track, and return investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliation
- Monitor 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
- Review and oversee regulatory documentations for accuracy and completeness and support assigned clinical sites with any regulatory concerns as appropriate
- Communicate 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
- Participate in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial
- Other duties as assigned
Skills
- 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
- Responsible for monitoring report writing and completion within required SOP and local regulatory parameters
- May be responsible for performing study start up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities
- Support development of study specific documentation related to monitoring activities as assigned
- Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements
- Review source document and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
- Manage, prepare, send, track, and return investigational supplies as assigned
- Monitor 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
- Review and oversee regulatory documentations for accuracy and completeness and support assigned clinical sites with any regulatory concerns as appropriate
- Communicate 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
- Participate in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial
- 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 local law, local regulatory requirements and 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
- Bachelor's degree or equivalent combination of education and experience
- > 5 years of experience as a Clinical Research Associate
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