Abbott Clinical Research Associate II in Burlington, Massachusetts
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Clinical Research Associate II. Working with a moderate level of guidance and direction, assists in the planning and conduct of Abbott clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures. Able to solve a range of straightforward problems and analyze possible solutions using standard procedures. Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing and trending compliance metrics . May contribute to developing study related materials. May also assist with the oversight of vendors such as core labs.
- Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to:
a.) Assists in the development of study related materials such as: patient brochures, patient
recruitment material, and presentations.
b.) Review and approval of site informed consent document to ensure all required elements are included.
c.) In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site.
d.) Coordinates activities with study vendor services, and core labs.
e.) Reviews and analyzes data and documents for accuracy and completeness. Creates and processes data queries.
f.) Reviews and processes product complaints and adverse events as soon as they are reported.
- Serves as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and escalating as appropriate.
a. Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory standards. Notify appropriate study management when concerns exist.
Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
Applies general clinical research processes and regulatory knowledge to process improvement activities.
A Bachelor degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
Minimum two years clinical research experience.
Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills
Ability to interpret basic clinical data, to meet deadlines
Ability to communicate effectively with all levels of employees
Familiarity with Microsoft word, Excel and Outlook programs and relevant clinical applications
The ability to work independently when necessary
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com