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Clinical Site Lead

Company: Abbott Laboratories
Location: Sacramento
Posted on: September 16, 2020

Job Description:

Medical and Clinical Affairs United States - California - Remote

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 103,000 colleagues serve people in more than 160 countries.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.

Our location in  Sacramento, CA and Bay Area Regions,  currently has an opportunity for a Clinical Site Lead . 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 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 DO

With limited direction from leadership:

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.

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.

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).

Possess independent problem-solving skills and ability to make decisions. Exhibit excellent oral and written communication skills.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

Bachelor’s Degree in engineering, biological sciences, nursing, equivalent or related certification in CRM.

Preferred

Advanced Practice Providers preferred.

Strong background with sponsor required require responsibilities in clinical trials.

Strong regulation background within clinical trials.

Two years of progressively more responsible relevant clinical trial experience in the cardiovascular field.

Competency in catheterizaion lab and operating room protocol and procedures.

Ability to travel approximately 50%, including internationally.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

Training and career development , with onboarding programs for new employees and tuition assistance

Financial security  through competitive compensation, incentives and retirement plans

Health care and well-being programs  including medical, dental, vision, wellness and occupational health programs

Paid time off

401(k)  retirement savings with a generous company match

The stability of a company  with a record of strong financial performance and history of being actively involved in local communities

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Get tailored job recommendations based on your interests. JOB ID: 30958024

LOCATION United States - California - Remote

DIVISION MD Medical Devices

TRAVEL Yes, 75 % of the Time

MEDICAL SURVEILLANCE Not Applicable

SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Continuous standing 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)

Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.

GROWTH PLANNING Growth Planning and Performance Excellence is an annual process through which you'll be able to have open career discussions with your manager to help you determine your own career path and future.

TRAINING & NETWORKS We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.

WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX BEST CORPORATE CITIZENS FORTUNE CHANGE ???????THE WORLD FORTUNE'S MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you about relevant positions, and keep you in mind whenever we have interesting opportunities.

Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans. We provide reasonable accommodation to qualified individuals with disabilities.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

Keywords: Abbott Laboratories, Sacramento , Clinical Site Lead, Other , Sacramento, California

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