NTD Staffing is looking for a CRA to support several studies from a site support trial operations perspective. Experience in Rare Disease studies is required. This position is a part time role, up to 20 hours per week, requiring Site Visits within the US and Canada.
Work with clinical site staff to obtain study data, ensure protocol compliance and ensure patient safety.
Provide training to site staff as required
Participate in internal and study site team meetings.
Support development and revisions of CRF’s, as needed, including review of EDC system.
Support the development of internal documents and study manuals as needed.
Be a conduit for field monitors as needed
Travel to and Perform Site Monitoring Visits
EDUCATION, SKILLS & COMPETENCIES:
Bachelor’s Degree, in nursing, life sciences or related field preferred
Minimum 4 years’ experience of clinical site monitoring, with additional site and project management preferred.
Experience with Veeva CTMS and eTMF required
Understanding and knowledge of current industry regulations and guidelines.
Strong organizational/communication skills and attention to detail.
Ability to work independently/exercise critical thinking while also being an active member of the internal team.
Willing to perform other work-related duties as assigned.
The above job description is intended to describe the key responsibilities but is not an exhaustive summary of all responsibilities, duties and skills that are required. The company reserves the right to vary the job descriptions as per their requirements.
All activities must be conducted in line with Harbor Clinical Policies and Standard Operating Procedures, other standard procedural documents that are contractually agreed for a given activity and all nationally and globally applicable laws, Regulations and Guidelines.