Clinical Site Lead- Phoenix, AZ

Main Responsibilities

• Develop and maintain a productive clinical territory
• Identify, develop, and maintain 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., operations management, study team, Site Contracts Associate), as needed.
• Manage all aspects of study lifecycle to include site regulatory and quality:
• Start Up
• Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
• Facilitate all aspects of the start-up process and site initiation visits.
• Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site 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 techniques that promote study goal achievement.
• Continuously evaluate site study performance and provide timely feedback to site.
• Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).
• Regulatory and Quality
• Core level Abbott certification and/or equivalent level proficiency.
• 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.
• Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.
• Review data and source documentation from investigational sites for accuracy and completeness.
• Facilitate resolution of data queries and action items at clinical sites.
• Promptly reports the findings of monitoring visits according to Abbott processes.
• Maintain accurate, detailed and complete records of monitoring visits.
• Provide training and procedure coverage:
• Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.
• When appropriate, collaborate in the education of local sales groups on new product launches.
• Contribute to the education of customers on new and existing Abbott products.
• Meet with key customers where Abbott GCO presence can elevate the customer experience.
• 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.
• Develop working knowledge of disease states and product lines for all relevant Abbott clinical trials.
• Upon leadership 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.

Required Qualifications

• Education: Associates Degree (± 13 years)
• Experience/Background: Minimum 1 year
• Preferred Qualifications: Bachelor’s Degree Or Master’s Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research. 2 + years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
• Competency: Ability to travel approximately 75%, including internationally.