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.

• Act as a knowledgeable resource in protocol implementation, product and disease-state expertise, procedure assistance, clinical trial enrollment, and adherence to ICH-GCP standards.

• Follow established site nomination, qualification, and startup procedures.

• Lead continuous training and retraining of site stakeholders to guarantee compliance with protocols.

• Manage and enhance site recruitment and data collection efficiency.

• Leverage operational metrics to reduce screen failures and participant attrition.

• Supervise site initiation, periodic, and close-out visits to ensure compliance with regulatory requirements, Good Clinical Practice, and accuracy.

• Assist in study design, site payments, audits, local document assessments, study document preparation, and submissions.

• Identify, cultivate, and sustain effective clinical sites in the Dallas area and its surroundings.

• Evaluate investigators’ interests and qualifications while identifying suitable candidates.

• Foster relationships with investigators, research coordinators, regulatory personnel, and legal teams.

• Provide technical assistance to customers and field personnel.

• Enhance communication between clinical sites and Abbott's clinical staff.

• Oversee site startup, qualification, initiation visits, enrollment, regulatory compliance, and quality assurance activities.

• Educate facility staff on protocol requirements and relevant technologies.

• Develop tailored enrollment and compliance strategies for specific sites.

• Attend study procedures and follow-ups or ensure that trained personnel are present.

• Gather essential documents and address missing data, corrections, adverse events, protocol deviations, data inquiries, and action items.

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

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

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

• Collaborate with commercial partners on product education and launch initiatives.

• Provide technical troubleshooting and customer support as needed.

• Stay updated on clinical, product, competitive, scientific, and economic knowledge.

• Serve as a local clinical and technical resource.

• Independently resolve issues and make informed decisions.

• Communicate effectively both orally and in writing.

⛳️ Requirements

• Associate's Degree.

• One year of relevant experience.

• Willingness to travel approximately 50% of the time.

• 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 two years of progressively responsible clinical trial experience in the cardiovascular domain (preferred).

• Proficiency in catheterization lab and operating room protocols and procedures (preferred).

🏝️ Benefits

• Opportunities for career development within an international organization.

• Complimentary medical coverage through the Health Investment Plan (HIP) PPO medical plan for eligible employees.

• Excellent retirement savings plan featuring high employer contributions.

• Tuition reimbursement available.

• Freedom 2 Save program for student debt.

• FreeU education benefit.

• Opportunities for personal and professional growth.

• Recognized as a great workplace and a top employer for diversity, working mothers, female executives, and scientists.