Job Details

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 114,000colleagues serve people in more than 160 countries.

The Opportunity:

Our location in Alameda, California is looking for a Clinical Data Specialist to join our team. In this role, you will provide clinical operational support to assigned clinical studies and projects. Interact with other departments and external suppliers and provide logistical support to clinical research teams. Perform responsibilities meeting project commitments and in compliance with applicable regulations, good clinical practice (GCP) and standards.

What you will do:

• Responsible for implementing and maintaining the effectiveness of the quality system.

• Conducts assigned clinical operations activities in accordance with applicable regulations; GCP, policies and procedures. May include the following activities:

• Facilitating the execution of new CDAs and Clinical Research Agreements and amendments

• Process and track payments related to executed Clinical Research Agreements

• Coordinate denied party screening and maintain reports and financial disclosures

• Coordinate orders and ship clinical supplies, instruments and specimens to sites for clinical studies

• Support internal audit and other compliance-related activities (e.g. preparation for audits, QA verification of clinical data, OEC review of Scientific Research and Publications, tracking of supplies for Sunshine Act reporting)

• Provide clinical study support to CRA's (e.g. prepare study master file binder, route clinical records, complete study related exception reports)

• Supports clinical research team with review and monitoring of clinical study data

• Identify the need for new processes and technologies to support an increase in quality, productivity and efficiency

• Identify and participate in process improvement initiatives. May participate in a lead role for a project

• Participate in training and educational opportunities for personal development and cross-training within the organization

• Other responsibilities as assigned

• Support current and new processes and procedures for the Clinical Research organization in accordance with applicable regulations; GCP; and ADD policies and procedures.

• Development and maintenance of Clinical Research procedures, templates and forms, routing of clinical procedures in APLM and support of new processes and technologies to support quality, productivity and efficiency of the Clinical Research organization.

In Addition:

• Accountable for completing operations activities per project timelines and elevating issues or concerns to appropriate management representatives with potential corrective actions identified.
• Responsible for compliance with applicable procedures, regulations and standards.

Requirements:

• B.S. in Biological Science or Medical Specialty preferred, Associates Degree required at a minimum.
• Knowledge of regulations and standards (GCP) affecting IVDs, and Biologics required.
• Minimum 3 years In a clinical research environment or a research laboratory with automated IVD assay/instrument experience, including data analysis.
• Experience with contracts and knowledge of electronic document management systems (e.g. APLM, SBM and other databases) desired

The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.