Sr. Clinical Trial Associate
il y a 7 jours
Cmed occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials but also as a developer of its own technologies for managing clinical data. Over the last 16 years this has included Timaeus® and now encapsia, a new game changing Cloud based Clinical Data Suite.
This is a very exciting time to join Cmed, as we start to leverage our already considerable expertise in the delivery of clinical trials with encapsia. This unique combination of operational expertise and the latest technology, helps reduce the costs and increase the speed of developing new medicines, essential to both improving and saving the lives of patients.
Core Accountabilities
Principal Responsibilities
Work with Project Leader, Lead CRA/CTL and CRAs to coordinate activities with the site in preparation for the initiation of studies, including start up activities and feasibility.
Assist the Lead CRA/CTL, CRAs, and site staff to obtain appropriate regulatory/IRB/IEC approval of study specific documents.
Review regulatory documentation for successful implementation, monitoring, and management of clinical trials.
Maintain Trial Master File according to Cmed SOPs and/or sponsor requirements.
Collect study-specific data (i.e., patient visit tracking, site visit tracking); enter data for project tracking in Clinical Trials Management System and update on an on-going basis.
Assist study team in providing ongoing support to site staff.
Essential Work Experience, Qualifications and Knowledge
Relevant experience or related education
Excellent written and verbal communication skills
Ability to multi-task, with strong attention to detail
Good organizational skills and customer service
Desirable Work Experience, Qualifications and Knowledge
Bachelor’s in life sciences strongly preferred
Experience in clinical trials and familiar with clinical trial methodology
**What we offer**:
Opportunity to be part of an innovative organization and work with exciting technologies
Mentorship and training to further develop your skills in the clinical trials industry
The chance to both lead and be part of an effective, dynamic, friendly, and supportive team
Competitive employment package
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