Clinical Site Lead

This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee the execution of studies and ensure operational excellence within Abbott Cardiovascular therapies.

• Assist in the implementation of protocols, provide product and disease-state knowledge, support procedures, evaluate procedure outcomes, identify trends, facilitate clinical trial enrollment, and apply ICH-GCP standards.

• Comply with site nomination, qualification, and startup protocols.

• Lead continuous training and retraining for site stakeholders to guarantee adherence to protocols.

• Manage site recruitment and performance in data collection, including enrollment, resolution of discrepancies, and ensuring compliance.

• Utilize operational metrics to reduce screen failure rates and attrition.

• Monitor adherence to regulatory requirements, Good Clinical Practice, and standards of accuracy through site initiation, periodic visits, and close-out reviews.

• Cultivate and maintain an effective clinical territory in the Dallas area along with qualified clinical sites.

• Evaluate and identify investigators based on study-specific and regulatory criteria.

• Build and sustain relationships with principal investigators, research coordinators, regulatory and legal personnel.

• Offer technical assistance to customers and field staff.

• Facilitate communication between clinical sites and Abbott clinical teams.

• Oversee study startup, enrollment, regulatory compliance, and quality assurance activities.

• Nominate and qualify sites, set execution expectations, and coordinate site initiation visits.

• Educate facility staff on protocol requirements and relevant technologies.

• Design site-specific strategies for enrollment and deviation avoidance.

• Assess site performance and provide constructive feedback.

• Participate in study procedures and follow-up visits, or ensure trained personnel are present.

• Collect essential documents, address missing data, and review adverse events and protocol deviations.

• Examine source documentation and investigational-site data for precision and completeness.

• Resolve data inquiries and action items efficiently.

• Document findings from monitoring visits and maintain comprehensive monitoring records.

• Train site and Abbott personnel for clinical trials and commercial launches.

• Collaborate with commercial partners on product education and customer support initiatives.

• Provide technical troubleshooting and clinical expertise as needed.

• Adapt to changing priorities and competing demands effectively.

• Maintain a strong area of clinical and technical expertise.

⛳️ Requirements

• Associate's Degree.

• Minimum of 1 year of relevant experience.

• Preferred: Bachelor’s or Master’s Degree in engineering, science, health science, nursing, or a related field, or equivalent experience in cardiology or clinical research.

• Preferred: More than 2 years of progressively responsible clinical trial experience in the cardiovascular domain.

• Preferred: Proficiency in catheterization lab and operating room protocols and procedures.

• Preferred: Willingness to travel approximately 50% of the time.

• Core level Abbott certification and/or equivalent proficiency.

• Exceptional oral and written communication skills.

• Strong independent problem-solving capabilities and decision-making skills.

• Ability to stay informed on clinical practices and Abbott product knowledge, competitive landscape, and scientific/economic literature.

🏝️ Benefits

• Opportunities for career development within an international company.

• Eligibility for free medical coverage through the Health Investment Plan (HIP) PPO medical plan.

• Retirement savings plan with a generous employer contribution.

• Tuition reimbursement program.

• Freedom 2 Save student debt assistance program.

• FreeU education benefit.

• Programs recognizing employee diversity and workplace excellence.