Senior Clinical Research Associate Level II & III (Home Base)
EM-US-SR-CRA- HB- 1003
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”
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 and experience. Experience in Pharmaceuticals / Medical Devices.
The Sr. CRA will conduct site visits to assess protocol and regulatory compliance and manages 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%
Education and 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
- Strong customer focus
- 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 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
- Effective presentation skills
- Therapeutic expertise, in Cardiovascular, CNS, Oncology, Ophthalmology, Infectious Diseases, Diagnostic Imaging, Pain Management and/or other.