Abbott Laboratories
Clinical Project Specialist - Medical Devices (Onsite)
Abbott Laboratories, Los Angeles, California, United States, 90079
Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream ofFree medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the
Freedom 2 Save
student debt program and
FreeU
education benefit - an affordable and convenient path to getting a bachelor’s degreeA company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by FortuneA company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientistsThe OpportunityWe are seeking a
Clinical Project Specialist
to join our Clinical Operations team on-site in
Sylmar, CA
for Medical Devices. This new team member will provide clinical operational support for multiple cardiac clinical studies and projects as well as serve as a liaison to the clinical project manager and other departments and external suppliers, providing logistical support to the clinical research teams. Additionally, performs responsibilities meeting project commitments and in compliance with applicable procedures, regulations and standards.What You’ll Work OnConduct assigned clinical operation activities under the supervision of Clinical Project Manager and in accordance with applicable regulations; GCP; and Division policies and procedures. May include the following activities:Coordinate the creation of clinical study materials for selection, qualification and activation of clinical study sites.Manage study-level communication with sites, e.g. share newsletters, annual/final reports.Partner with Marketing to develop Diversity and Inclusion patient access materials.Coordinate study close out process.Coordinate the global review and approval process for site activation.Ensure audit readiness for assigned studies.Prepare study newsletters.Complete Central IRB submissions.Routing of documents for signature.Define clinical study SharePoint structure and maintain site.Develop document management plan and maintain at the study level, including setup of individual studies and uploading documentation.Support management of 3rd party suppliers/corelabs and tracking of their deliverables.Required QualificationsBachelor's degree requiredMinimum of 2 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.Good knowledge and application of business concepts, procedures and practices.Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.Learns to use professional concepts and company policies and procedures to solve routine problems.Works on problems of limited scope. Minimal independent decision making.Preferred QualificationsBachelors in Biological Science or Medical Specialty preferredKnowledge of regulations and standards (GCP) affecting implantable medical devices.Ability to work in a matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and/or engage others to accomplish projects.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes and meets deadlines in a timely manner.Strong organizational and follow-up skills, as well as attention to detail.Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews.
#J-18808-Ljbffr
Freedom 2 Save
student debt program and
FreeU
education benefit - an affordable and convenient path to getting a bachelor’s degreeA company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by FortuneA company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientistsThe OpportunityWe are seeking a
Clinical Project Specialist
to join our Clinical Operations team on-site in
Sylmar, CA
for Medical Devices. This new team member will provide clinical operational support for multiple cardiac clinical studies and projects as well as serve as a liaison to the clinical project manager and other departments and external suppliers, providing logistical support to the clinical research teams. Additionally, performs responsibilities meeting project commitments and in compliance with applicable procedures, regulations and standards.What You’ll Work OnConduct assigned clinical operation activities under the supervision of Clinical Project Manager and in accordance with applicable regulations; GCP; and Division policies and procedures. May include the following activities:Coordinate the creation of clinical study materials for selection, qualification and activation of clinical study sites.Manage study-level communication with sites, e.g. share newsletters, annual/final reports.Partner with Marketing to develop Diversity and Inclusion patient access materials.Coordinate study close out process.Coordinate the global review and approval process for site activation.Ensure audit readiness for assigned studies.Prepare study newsletters.Complete Central IRB submissions.Routing of documents for signature.Define clinical study SharePoint structure and maintain site.Develop document management plan and maintain at the study level, including setup of individual studies and uploading documentation.Support management of 3rd party suppliers/corelabs and tracking of their deliverables.Required QualificationsBachelor's degree requiredMinimum of 2 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.Good knowledge and application of business concepts, procedures and practices.Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.Learns to use professional concepts and company policies and procedures to solve routine problems.Works on problems of limited scope. Minimal independent decision making.Preferred QualificationsBachelors in Biological Science or Medical Specialty preferredKnowledge of regulations and standards (GCP) affecting implantable medical devices.Ability to work in a matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and/or engage others to accomplish projects.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes and meets deadlines in a timely manner.Strong organizational and follow-up skills, as well as attention to detail.Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews.
#J-18808-Ljbffr