Clinical Site Lead Boston, MA

Summary

The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular Cardiac Rhythm Management EP Structural Heart and Heart Failure). Recognized resource in protocol execution increasing product and disease state knowledge procedure support (as needed) procedure outcomes and earlyindicationof trends clinical trial enrollment and ICH-GCP and clinical researchapplication.

Adheres to specified site nomination qualification and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence.Continuouslyreviews manages and influences all aspects ofsitesrecruitment and data collection performance (enrollment discrepancy resolution compliance etc.). Proactivelyutilizesappropriate operationalmetrics 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.

Main Responsibilities

With limited direction from leadership:

1. Develop andmaintaina productive clinical territory:

Identify develop andmaintainsites capable of delivering start-up goals study participationlevelsanddata quality.

Understand and assess investigators interests and qualifications.

Identifyappropriate investigatorsas defined by study-specific requirements and by the applicable regulatory code.

Maintain open communication and relationships with key site personnel including thePrincipleInvestigator 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.

2. 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 forappropriate collaborationwith Abbott clinical staffe.g.Site CRA Site Contract Associate.

Train facility staffregardingprotocol requirements and technology.

Enrollment

Develop site-specific strategies to promoteappropriate patientenrollment.

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

Continuously evaluate site study performance and providetimelyfeedback to site.

Attend study procedures and follow-ups whenindicated(or ensure trained personnelattend).

Regulatory and Quality

Core level Abbott certification and/or equivalent levelproficiency

Develop site-specific strategies to avoid deviations.

Educatesite ontools tofacilitatecompliance.

Providetimelyfeedback to the sites on key compliance indicators.

Escalate non-compliant sites according to corporate policy.

Collect essential documentsidentifyand 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.

Maintainaccuratedetailedand complete records of monitoring visits.

3. 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 technicalexpertisefor clinical trial procedure support

Attend study procedures and follow-ups (or ensure trained personnelattend).

4. Collaborate with commercial partners:

Whenappropriate collaborate in the education of local sales groups on new product launches.

Whenappropriate 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 anadditionalresource for technical questions and troubleshooting.

5.Identifyand adapt to shifting priorities and competing demands.

6. Remain current on developments in the field ofexpertiseincluding 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.

7.Possessindependent problem-solving skills and ability to make decisions.

8. Exhibit excellent oral and written communication skills.

REQUIREDQUALIFICATIONS

Education

• Associates Degree(13 years)

Experience/Background

• Minimum 1 year

PREFERRED QUALIFICATIONS

• Bachelors Degree Or MastersDegree 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 incatheterizaionlab and operating room protocol and procedures.

• Ability to travel approximately 75% including internationally.