Senior CRA
U.S. reputed company
Business Title
Senior Clinical Research Associate reputed company & III (Home reputed company)
reputed company
EM-US-SR-CRA- HB- 1003
Job Category
Clinical Research
Locations
US reputed company-reputed company. 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 reputed company
The reputed company Senior Clinical Research Associate (CRA) Home reputed company performs and coordinates reputed company 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 reputed company Operating Procedures and experience. Experience in Pharmaceuticals / Medical Devices.
The Sr. CRA will conduct site reputed company to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international reputed company assurance audits. Represents ESTERN Medical in the global medical research community and develops and maintains reputed company relationships with investigational sites and reputed company company personnel. May assist project manager or clinical team manager on assigned reputed company 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 reputed company 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, reputed company 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 reputed company Operating Procedures
Ability to mentor and train other monitors in a reputed company 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
Strong customer reputed company
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 constantly changing environment.
Good computer skills:
Good knowledge of reputed company 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
Effective presentation skills
Therapeutic expertise, in Cardiovascular, CNS, Oncology, Ophthalmology, Infectious Diseases, Diagnostic Imaging, reputed company and/or other.
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