What are the responsibilities and job description for the Clinical Research Coordinator position at Abbott?
The Opportunity
This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
This position 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’ll Work On
- 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
- Support current and new processes and procedures for the Clinical Research organization in accordance with applicable regulations; GCP; and ADD policies and procedures. This may include :
- Development and maintenance of Clinical Research procedures, templates and forms
- Routing of clinical procedures in APLM
- Support of new processes and technologies to support quality, productivity and efficiency of the Clinical Research organization
- Supervisory / Management Responsibilities : None
- Position Accountability / Scope
- 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.
- This position performs tasks and responsibilities under the general direction of the Clinical Operations Manager or Clinical Research Manager.
Required Qualifications
