Abbott Field Clinical Operations Specialist II- Atlanta in Abbott Park, Illinois

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

With limited direction from FCA Management:

Maintain and develop a productive clinical territory:

  • Identify and develop sites capable of delivering start-up goals, study participation levels and required data quality.

  • Understand and assess investigators’ interests and qualifications.

  • Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.

  • Maintain open communication and relationships with key site personnel including the Principle Investigator, Research Coordinator, as well as regulatory and legal personnel.

  • Provide ongoing technical support to customers and field staff.

  • Facilitate communication between clinical sites and other Abbott clinical staff (e.g., FCRA, CRA, study team, Contracts Associate), as needed.

Manage all aspects of study progress:

  • Start Up

  • Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.

  • Facilitate all aspects of the start-up process.

  • Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff e.g, CRA, Contract Associate.

  • Train facility staff regarding protocol requirements and technology.

  • Enrollment

  • Develop site-specific strategies to promote appropriate patient enrollment.

  • Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement.

  • Continuously evaluate site study performance and provide timely feedback to site.

  • Attend study procedures and follow-ups (or ensure trained personnel attend).

  • Protocol and Regulatory Compliance

  • Develop site-specific strategies to avoid deviations.

  • Educate site on tools to facilitate compliance.

  • Provide timely feedback to the sites on key compliance indicators.

  • Escalate non-compliant sites according to corporate policy.

Provide training and procedure coverage:

  • Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.

  • Provide clinical and technical expertise for clinical trial procedure support.

  • Attend study procedures and follow-ups (or ensure trained personnel attend).

Collaborate with commercial partners:

  • When appropriate, collaborate in the education of local sales groups on new product launches.

  • When appropriate, contribute to the education of customers on new and existing Abbott products.

  • Meet with key customers where FCA staff presence can elevate the customer experience.

  • Act as an additional resource for technical questions and troubleshooting.

Identify and adapt to shifting priorities and competing demands. Remain current on developments in the field of expertise including clinical and Abbott product knowledge, competitive positioning and published scientific and economic evidence.

  • Maintain at least one area of expertise and function as a local clinical and technical resource.

  • Develop working knowledge of disease states and product lines for all relevant Abbott clinical trials.

  • Upon FCA Director approval, complete and maintain certifications that are relevant to specific field(s) of expertise (where appropriate).

Possess independent problem-solving skills and ability to make decisions. Exhibit excellent oral and written communication skills.

Q ualifications:

  • Bachelor’s Degree in engineering, biological sciences, or a related field, OR equivalent or related experience in cardiology or clinical research.

  • 3 years of progressively more responsible relevant clinical work experience in the cardiovascular field.

  • High level of competency in cath lab and operating room protocol and procedures.

  • Ability to travel approximately 75%, including internationally.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com