- Responsible for the design, execution and monitoring of internal clinical studies.
- Participate in the design, training and monitoring of Abbott sponsored external clinical studies including PMA and outcome studies.
- Participates in identification and qualification of external clinical sites.
- Participates in the development and maintaining of standard operating procedures.
- Participates in cross functional team activities for product development.
- Effectively communicates the outcomes of the study to cross functional teams.
- Perform study site visits (SQV, SIV, IMV, COV), ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements, generating monitoring trip reports, and track resolution of action items.
- Participate in study start up activities.
- Responsible for ensuring shipment of study devices and supplies to clinical sites and performing study device accountability.
- Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.
- Maintain and audit Trial Master File to ensure inspection readiness.
- Perform review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed·
- Proactively and effectively communicate the status of clinical studies to management.
- Ensures quality delivery of study deliverables within agreed budgets and timelines.
- Participate in the interim and final reviews of study data in preparation of regulatory submissions.
- Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).
- May interact with RA/QA in responding to audits and FDA inquiries.
- BS degree in life sciences with six years of experience as a CRA or CRC or combination of appropriate education and experiences required.
- Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations.
- Experience in conducting medical device and/or diagnostics studies. Pharmaceutical background may also be considered.
- Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
- Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
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Clinical Research Associate III - Alameda, United States - Abbott
Description
The Opportunity
The Associate Clinical Research III will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.
What You'll Work On
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Required Qualifications
