Senior Clinical Research Associate Level II & III (Home Base)
Requisition ID
EM-US-SR-CRA- HB- 1003
Job Category
Clinical Research
Locations
US North America-United States. Please note candidates currently residing preferably in the following states but not limited to: AZ, MA, CA, CT, FL, ME, MD, NC, NH, NJ, NY, PA, RI, TX, VA, WV.
Job Description
The experienced Senior Clinical Research Associate (CRA) Home Base performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/EMEA, and preferably some knowledge of Latin America/South American local guidelines, local regulations, and ESTERN Medical Standard Operating Procedures. The Sr. CRA will conduct site visits to assess protocol and regulatory compliance and manage required documentation. Responsible for ensuring that data will pass international quality assurance audits. Represents ESTERN Medical in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team. Required to travel 25-50%.
Requirements
Education & Experience:
Bachelor's degree in a science-related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution with significant clinical research monitoring experience (comparable to at least 3-5 years) that provides the required knowledge, skills, and abilities and experience mentoring or training others. In some cases, an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills, and Abilities may be considered.
Knowledge, Skills and Abilities:
Effective clinical monitoring skills
Excellent understanding and demonstrated application of FDA/EMEA and preferably some Latin American/South American guidelines, Good Clinical Practices and applicable Standard Operating Procedures
Ability to mentor and train other monitors in a positive and effective manner
Ability to evaluate medical research data and proficient knowledge of medical terminology
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Excellent interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Proven flexibility and adaptability
Excellent team player with team building skills
Ability to work independently as required
Ability to utilize problem-solving techniques applicable to a constantly changing environment
Good knowledge of Microsoft Office and the ability to learn appropriate software
Excellent English and also preferably knowledge of some mid-level Spanish or Portuguese language and grammar skills
Therapeutic expertise in Cardiovascular, CNS, Oncology, Ophthalmology, Infectious Diseases, Diagnostic Imaging, Pain Management and/or others.
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