Associate Clinical Site Lead

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.We’realways looking towards the future,anticipatingchanges in medical science and technology.

Working at Abbott

At 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’llalso have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, andFreeUeducation benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized asa great placeto work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Associate Clinical Site Lead for the Atlanta, GAregion 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 earlyindicationof 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.Continuouslyreviews, manages, and influences all aspects ofsite’srecruitment 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.

What You'll Work On

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

Develop and maintaina productive clinical territory:

• Identify, develop, andmaintainsites capable of delivering start-up goals, study participationlevelsandrequireddata 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.

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 staff,e.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

• Strong understanding of GCP and commitment to progress knowledge and achieve Abbott certifications
• Develop site-specific strategies to avoid deviations.
• Educatesite ontools tofacilitatecompliance.
• Providestimelyfeedback to the sites on key compliance indicators.
• Escalate non-compliant sites according to corporate policy.
• Collect essential documents,identifyand 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.
• Maintainaccurate,detailedand 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 technicalexpertisefor clinical trial procedure support
• Attend study procedures and follow-ups (or ensure trained personnelattend).

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.

Identify and adapt to shifting priorities and competing demands. 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.
• Develop working knowledge of disease states and product lines for all relevant Abbott clinical trials.
• Upon leadership approval, complete andmaintaincertifications that are relevant to specific field(s) ofexpertise(whereappropriate).

Education and Experience You’llBring:

Required

• Associate’s degree
• Minimum 1 year experience

Preferred

• Bachelor’s Degree in engineering, science, health science, nursing, ora relatedfield, 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.

The base pay for this position is

$50,700.00 – $101,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

MD Medical Devices

LOCATION:

United States of America : Remote

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 75 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf