Abbott Safety CRA II in Plymouth, Minnesota
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, adverse event handling and review in accordance with 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 management of Clinical Endpoint Committee (CEC) activities such as collection and review of essential source documentation for completeness and accuracy, identifying and obtaining missing data, data corrections, reviewing and trending metrics. May contribute to developing safety process materials. Participate and assist with the conduct of CEC and Data Safety Management Board (DSMB) meetings across different studies.
- Ensures both regulatory and clinical protocol compliance is maintained for all required reportable adverse events for the assigned clinical studies. This may include but is not limited to:
Review of study protocol requirements and study safety plan for reportable adverse events. Perform a thorough review of submitted source documentation for completeness, accuracy and identification of any unreported events or product complaints. Reviews and analyzes data and generates queries for missing or discrepant data. Assist in the development of safety processes, committee charters and other safety related documents. Assist in conduct of and participate in CEC meetings for assigned studies. Collaborate with other team members to develop report specifications and review AE adjudication metrics for assigned studies to ensure timely, effective and efficient review of events by CEC
Serves as a liaison to clinical safety management and study management, by identifying any potential safety trends and escalating as appropriate.
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
Experience in conduct and management of clinical endpoint committee and/or data safety monitoring board
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