Associate Clinical Site Lead – Northern CA

The Opportunity

The Associate Clinical Site Lead for the Northern California region drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure).

Developing skills and foundation to become a resource in protocol execution, developing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application.

Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training / retraining of all site stakeholders to ensure protocol adherence.

Continuously reviews, manages, and influences all aspects of site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.

Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.

May be consulted in the following areas : study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority / ethics committee.

What You'll Work On

With supervision of senior colleague / manager (or delegate) :

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 visitsUnderstand 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 Strong understanding of GCP and commitment to progress knowledge and achieve Abbott certificationsDevelop 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 completenessFacilitate resolution of data queries and action items at clinical sitesPromptly 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.
• As needed, 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 Abbott GCO 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 leadership approval, complete and maintain certifications that are relevant to specific field(s) of expertise (where appropriate).

Education and Experience You’ll Bring :

Required

• Associate’s degree
• Minimum 1 year experience

Preferred

• Bachelor’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 in catheterization lab and operating room protocol and procedures.
• Possess independent problem-solving skills and ability to make decisions.
• Exhibit excellent oral and written communication skills.
5 days ago