Clinical Site Lead – Atlanta, GA Territory

Abbott; Atlanta (GA); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott is seeking a Clinical Site Lead for the Atlanta, GA territory to drive study execution and operational excellence across cardiovascular therapies. You will oversee site qualification, enrollment strategies, data quality, and regulatory compliance while training site staff and collaborating with Abbott teams.

The role requires an Associate degree with 1 year of experience; a Bachelor’s or Master’s in a relevant field is preferred, plus ~50% travel.

Qualifications

• Associates Degree required.
• 1 year experience required.
• Bachelor's or Master’s degree preferred in related field (engineering, science, health science, nursing) or equivalent/related clinical research experience.

Responsibilities

• Develop and maintain a productive clinical territory.
• Manage all aspects of the study lifecycle including site regulatory and quality.
• Provide training and procedure coverage for trial procedures and site personnel.
• Collaborate with commercial partners for education on new products and launches.
• Identify shifting priorities and adapt to changing demands.

Education

Associates Degree

Bachelor’s Degree Or Master’s Degree in engineering, science, health science, nursing, or related field

Job description

Clinical Site Lead – Atlanta, GA Territory

Location United States - Georgia - Atlanta Category Medical and Clinical Affairs

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

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’ll also 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 high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

We are recruiting for a Clinical Site Lead to join our field team for the Atlanta, GA and surrounding territory. The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). This new team member is a recognized resource in protocol execution, increasing 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.

Additionally, adheres to specified site nomination, qualification, and startup processes. In this role you will lead ongoing training/retraining of all site stakeholders to ensure protocol adherence as well as continuously review, manage, and influence all aspects of site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). The individual proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. and monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close‑out visits.

They may also 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 limited direction from leadership:

1. Develop andmaintaina 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.

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 staff,e.g.Site CRA, Site Contract Associate.
• Train facility staffregardingprotocol requirements and technology.
• 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 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.

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.

Required Qualifications

• Associates Degree
• 1 year experience

Preferred Qualifications

• Bachelor’s Degree Or Master’sDegree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology orclinical research.
• 2 + years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
• Competency incatheterizationlab and operating room protocol and procedures.
• Ability to travel approximately 50%.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and

Job Id 31165197 LocationUnited States - Georgia - Atlanta Medical surveillance No Division MD Medical Devices Travel Yes, 75 % of the Time Additional Location 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)

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An Equal Opportunity EmployerAbbott is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Employment decisions are based on qualifications, merit, and business needs. EEO (ENGLISH) EEO (SPANISH) PAY TRANSPARENCY NONDISCRIMINATION PROVISION We provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340or email [e-mail] . Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, and gender-neutral criteria in compliance with applicable laws and local regulations.