Clinical Research Associate - Rare Disease

Job description

Harbor Clinical is seeking an experienced Clinical Research Associate (CRA) with Rare Disease experience, specifically von Willebrand or bleeding disorders. The expectation is that the CRA will have a clinical background and be comfortable speaking with physicians and nurses about the sponsors clinical product and the procedure that is the subject of the trial. We are seeking to fill 2 positions one based in the US or Canada and the second in the United Kingdom to support the global trial.

Responsibilities:

• Travel to defined sites to attend scheduled procedures and be comfortable speaking to physicians and nurses about protocol adherence
• 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 the development of internal documents and study manuals as needed.
• Develops high standards of excellence in own work
• Independently determines and develops approaches to solutions
• Identifies opportunities for improvement or efficiency of technical processes; develops and applies creative/technical ideas to projects
• Works under general direction and wiling to perform other work related duties as assigned
• Uses judgments within defined policies and practices
• Follows through on commitments
• Executes work quickly and efficiently
• Adapts to multiple demands and adapts to changes in business requirements, shifting priorities and ambiguities
• Tailors communication medium to effectively reach audience and effectively uses technology to communicate

Qualifications

• 3 to 5 years’ experience of clinical site monitoring, with additional site and project management preferred.
• Experience and comfortable speaking to physicians and nurses
• von Willebrand or bleeding disorder condition experience required
• Experience with Veeva CTMS and eTMF helpful
• Understanding and knowledge of current industry regulations and guidelines.
• Strong organizational/communication skills and attention to detail.
• Ability to independently oversee sites and handle not only monitoring responsibility but also oversee site management activities (i.e., regulatory document collection, assigning site staff training, informed consent review, assist site with IRB submissions and all other required activities).