Clinical Research Associate II
1. 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.
2. 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.
3. Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
4. Applies general clinical research processes and regulatory knowledge to process improvement activities.
JOB FAMILY:Clinical Affairs / Statistics
DIVISION:MD Medical Devices
LOCATION:United States > Minnesota : 5050 Nathan Lane N.
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf