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Sr. Clinical Trial Specialist

Ampcus Inc. Cincinnati Contractor
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Description:

The senior CTS position supports complex clinical trial activities. Partners with CTM/CPM to ensure site related start up through close out activities are conducted as per GCP, and regulatory requirements. Vendor oversight and management is required and identifies issues in a timely manner and escalates to management as appropriate. Will complete monitor trip report review, and monitor on site to assess for quality, GCP and regulatory compliance. The senior CTS position supports complex clinical trial activities. Partners with CTM/CPM to ensure site related start up through close out activities are conducted as per GCP, and regulatory requirements. Vendor oversight and management is required and identifies issues in a timely manner and escalates to management as appropriate. Will complete monitor trip report review, site audit reports and monitors on site to assess for quality, GCP and regulatory compliance. Major Duties & Responsibilities: - Monitors clinical studies for adherence to protocol, ICH/GCP, SOP's and follows Clinical Monitoring Plan i.e. on site quality visits, review & approve trip reports, monitor metrics of vendor/site performance. - Ensures quality of data generated from clinical sites and assist in resolving subject eligibility/protocol deviations issues and confirms accuracy of clinical data. Works closely with CTM and Data Management lead to develop data quality plans and processes. - Ensures safety issues are reported and follow up issues are closed within expected timeframe. Develops and maintains guidance and process instruction documents, maintain study documents (consent templates, site procedural instructions etc.). - Responsibility to ensure site enrollment metrics are closely tracked to identify risk and elevate as appropriate to support enrollment goals. The tracking of essential documents are received /approved & filed for the duration of the study. Reviews/approves site ICF's for continuity and follow up with functional leads as appropriate. Computer skills (Microsoft office; Word, Excel, PowerPoint), at least had 4 years clinical research experience, good organizational skills, good knowledge of concepts of clinical research and drug development, general therapeutic area education and training i.e. nursing, medical, strong problem solving skills and a good understanding of issue escalation, good communication skills, ability to functional well in team environment. - 11-20% Domestic/International travel on the job. Preferred Qualifications: - CRA field monitoring. Preferred industry experience in Medical Device, Pharmaceutical, Biotech, CRO.
Description:

The senior CTS position supports complex clinical trial activities. Partners with CTM/CPM to ensure site related start up through close out activities are conducted as per GCP, and regulatory requirements. Vendor oversight and management is required and identifies issues in a timely manner and escalates to management as appropriate. Will complete monitor trip report review, and monitor on site to assess for quality, GCP and regulatory compliance. The senior CTS position supports complex clinical trial activities. Partners with CTM/CPM to ensure site related start up through close out activities are conducted as per GCP, and regulatory requirements. Vendor oversight and management is required and identifies issues in a timely manner and escalates to management as appropriate. Will complete monitor trip report review, site audit reports and monitors on site to assess for quality, GCP and regulatory compliance. Major Duties & Responsibilities: - Monitors clinical studies for adherence to protocol, ICH/GCP, SOP's and follows Clinical Monitoring Plan i.e. on site quality visits, review & approve trip reports, monitor metrics of vendor/site performance. - Ensures quality of data generated from clinical sites and assist in resolving subject eligibility/protocol deviations issues and confirms accuracy of clinical data. Works closely with CTM and Data Management lead to develop data quality plans and processes. - Ensures safety issues are reported and follow up issues are closed within expected timeframe. Develops and maintains guidance and process instruction documents, maintain study documents (consent templates, site procedural instructions etc.). - Responsibility to ensure site enrollment metrics are closely tracked to identify risk and elevate as appropriate to support enrollment goals. The tracking of essential documents are received /approved & filed for the duration of the study. Reviews/approves site ICF's for continuity and follow up with functional leads as appropriate. Computer skills (Microsoft office; Word, Excel, PowerPoint), at least had 4 years clinical research experience, good organizational skills, good knowledge of concepts of clinical research and drug development, general therapeutic area education and training i.e. nursing, medical, strong problem solving skills and a good understanding of issue escalation, good communication skills, ability to functional well in team environment. - 11-20% Domestic/International travel on the job. Preferred Qualifications: - CRA field monitoring. Preferred industry experience in Medical Device, Pharmaceutical, Biotech, CRO.

Recommended skills

Clinical Research
Good Clinical Practices (Gcp)
Clinical Research Associate
Drug Development
Communication
Computer Literacy

Location

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Ampcus Inc., headquartered in Chantilly, Virginia is certified by SBA, USPAACC, WBENC. VMSDC as a leading 8(a), Minority and Women owned Professional services and Staff Augmentation firm. Our repeat business rate with our various clients has been remarkable and the extension of contracts with various clients stands testimony to our high commitment levels. Ampcus is proud of our high employee retention rate thereby ensuring that the work performed at our various client sites is smooth and efficient at all times.

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