Safety CRA I

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job description-CRA I (Clinical Safety)

We are seeking an enthusiastic, motivated Clinical Research Associate I. 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. Assist with solving a range of straightforward problems and analyzing 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. Assist with developing safety process materials. Participate and assist with the conduct of CEC and Data Safety Management Board (DSMB) meetings across different studies.

Job Duties:

1. 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

2. Serves as a liaison to clinical safety management and study management, by identifying any potential safety trends and escalating as appropriate.

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.

Qualifications:

Minimum Education Required:

Bachelors degree plus 0-2 years of related work experience with an understanding of specified functional area, or an equivalent combination of education and work experience.

Minimum Training & Experience Required:

1) Life sciences background. (2) Knowledgeable in good clinical practices, especially in medical devices or IVDs.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: