Abbott
Healthcare
ClinicalSiteLead
“Clinical Site Lead at Abbott. Skills: Clinical trial execution, Site management, Protocol adherence, Data quality. Drive study execution. Ensure operational excellence”
What You'll Achieve.
Deliver start-up goals; Achieve study participation levels; Achieve required data quality; Achieve study goal achievement
Industry & Context.
Independent problem-solving
Travel 75% international
What They're Looking For.
Must Have
Associate's Degree, Minimum 1 year experience
Nice to Have
Bachelor's Degree or Master's Degree, 2+ years cardiovascular clinical trial experience, Competency in catheterization lab, Competency in operating room procedures, Ability to travel approximately 75%
What You'll Do.
Drive study execution
Ensure operational excellence
Adhere to site nomination processes
Adhere to qualification processes
Adhere to startup processes
Lead ongoing training
Ensure protocol adherence
Review site recruitment performance
Manage site data collection performance
Minimize screen failure rate
Minimize attrition rate
Ensure compliance with regulatory requirements
Ensure compliance with Good Clinical Practice
Ensure accuracy standards
Conduct site initiation visits
Conduct periodic visits
Conduct close-out visits
Develop productive clinical territory
Identify capable sites
Develop capable sites
Maintain capable sites
Assess investigator qualifications
Identify appropriate investigators
Maintain open communication with site personnel
Maintain relationships with site personnel
Provide ongoing technical support
Facilitate communication between sites
Facilitate communication with Abbott clinical staff
Complete qualification processes
Establish site expectations
Establish sponsor expectations
Facilitate start-up process
Facilitate site initiation visits
Collaborate with Abbott clinical staff
Train facility staff regarding protocol requirements
Train facility staff regarding technology
Develop site-specific enrollment strategies
Promote appropriate patient enrollment
Identify site successes
Identify site challenges
Implement techniques for goal achievement
Evaluate site study performance
Provide feedback to site
Attend study procedures
Attend study follow-ups
Ensure trained personnel attend procedures
Ensure trained personnel attend follow-ups
Develop site-specific deviation avoidance strategies
Educate site on compliance tools
Provide feedback on compliance indicators
Escalate non-compliant sites
Collect essential documents
Obtain data corrections
Review adverse events
Review protocol deviations
Review data for accuracy
Review data for completeness
Review source documentation for accuracy
Review source documentation for completeness
Facilitate resolution of data queries
Facilitate resolution of action items
Report findings of monitoring visits
Maintain accurate records of monitoring visits
Maintain detailed records of monitoring visits
Maintain complete records of monitoring visits
Apply clinical expertise to train staff
Apply technical expertise to train staff
Provide clinical expertise for procedure support
Provide technical expertise for procedure support
Collaborate in education of sales groups
Contribute to education of customers
Meet with key customers
Act as resource for technical questions
Act as resource for troubleshooting
Identify shifting priorities
Adapt to shifting priorities
Identify competing demands
Adapt to competing demands
Remain current on developments
Maintain area of expertise
Function as local clinical resource
Function as local technical resource
Possess independent problem-solving skills
How You'll Work.
Team & Collaboration
Site personnel; Abbott clinical staff; Commercial partners; Local sales groups
Communication Scope
Oral communication; Written communication
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