Clinical Site Lead
About The Position
Abbott is recruiting a Clinical Site Lead for its field team covering Houston and the surrounding territory, including parts of Texas and Oklahoma. The role drives study execution and operational excellence across Abbott Cardiovascular therapies, including Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure. The Clinical Site Lead serves as a resource for protocol execution, product and disease-state knowledge, procedure support as needed, procedure outcomes and trend identification, clinical trial enrollment, and the application of ICH-GCP and clinical research practices. The role supports site nomination, qualification, and startup; trains and retrains site stakeholders on protocol adherence; and reviews and influences site recruitment and data-collection performance. It uses operational metrics to address screen failures and attrition, and monitors compliance with regulatory requirements, Good Clinical Practice, and accuracy standards through site initiation, periodic, and close-out visits. The position may also provide input on study design, site payments, audits, local document review, study-document preparation, and submissions to sites or competent authorities and ethics committees.
Requirements
- Bachelor’s degree in engineering, science, health science, nursing, or a related field, or equivalent or related experience in cardiology or clinical research.
- At least 2 years of progressively responsible relevant clinical trial experience in the cardiovascular field.
- Ability to travel approximately 50%.
Nice To Haves
- Competency in catheterization lab and operating room protocols and procedures.
Responsibilities
- Develop and maintain a productive clinical territory by identifying and maintaining sites able to meet study startup, participation, and data-quality goals.
- Assess investigators’ interests and qualifications and identify investigators according to study-specific requirements and applicable regulations.
- Maintain relationships and communication with investigators, research coordinators, regulatory and legal personnel, and other key site staff.
- Provide technical support to customers and field staff and facilitate communication between clinical sites and Abbott clinical staff.
- Nominate, approach, qualify, and start up sites, establishing expectations for study execution and facilitating site initiation visits.
- Collaborate with Abbott clinical staff on regulatory and legal requirements for study participation.
- Train facility staff on protocol requirements and technology.
- Develop site-specific patient-enrollment strategies, identify site challenges and successes, and provide timely performance feedback.
- Attend study procedures and follow-ups when indicated, or ensure trained personnel attend.
- Develop strategies to prevent protocol deviations, educate sites about compliance tools, provide feedback on compliance indicators, and escalate non-compliant sites according to company policy.
- Collect essential documents, obtain missing data, make data corrections, and review adverse events and protocol deviations.
- Review site data and source documentation for accuracy and completeness; facilitate resolution of data queries and action items.
- Report monitoring-visit findings promptly and maintain accurate, detailed records of monitoring visits.
- Train site and Abbott staff for clinical trials and applicable commercial launches, and provide clinical and technical procedure support as needed.
- Collaborate with commercial partners on education about product launches and Abbott products, meet with key customers where appropriate, and provide technical troubleshooting support.
- Adapt to shifting priorities and competing demands; remain current on clinical, product, competitive, and published scientific and economic developments.
- Maintain at least one area of expertise and serve as a local clinical and technical resource.
- Apply independent problem-solving and decision-making skills and communicate effectively in writing and orally.
Benefits
- Career development opportunities with an international company.
- Potential eligibility for free medical coverage in the Health Investment Plan PPO in the next calendar year.
- Retirement savings plan with high employer contribution.
- Tuition reimbursement.
- Freedom 2 Save student debt program.
- FreeU education benefit.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
