Supervisor, ACPRU Cardiac Clinical Research Technician

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Purpose:

The Cardiac Clinical Research Technician (CRT) Supervisor will support the conduct of clinical research trials at the AbbVie Clinical Pharmacology Research Unit (ACPRU) in accordance with all Regulatory and AbbVie requirements. They will monitor and ensure the safety of subjects participating in clinical research trials at ACPRU.
-Monitor and ensure safety of ACPRU clinical research trial participants
-Technical Subject Matter Expert for cardiograph and telemetry system at the ACPRU
-Responsible for cardiac related data management activities and operations for new and ongoing clinical research studies
-Coordinate and assist in execution of Phase 1 studies at ACPRU
-Direct ACPRU Technician staff. Ensure staff is properly trained and appropriately assigned to responsibilities based on training level and experience
-Work closely with CRT Manager

• Will manage approximately 5 Telemetry Monitor Technician direct reports.
• Supervise the electrocardiogram (ECG) collection and cardiac monitoring activities performed during the conduct of clinical research studies at the ACPRU.Supervise the electrocardiogram (ECG) collection and cardiac monitoring activities performed during the conduct of clinical research studies at the ACPRU.
• Assist with ABBIOS Study Management Tool configuration and data reconciliation for external clinical studies.Assist with ABBIOS Study Management Tool configuration and data reconciliation for external clinical studies.
• Collaborate with IT and other support personnel to ensure accurate documentation, testing, validation, and implementation of cardiac related data management systems and process improvements/upgrades.Collaborate with IT and other support personnel to ensure accurate documentation, testing, validation, and implementation of cardiac related data management systems and process improvements/upgrades.
• Review draft protocols and provide comment on aspects which impact telemetry technician duties, ACPRU workflow and operational aspects of the studies conducted at the ACPRU.Review draft protocols and provide comment on aspects which impact telemetry technician duties, ACPRU workflow and operational aspects of the studies conducted at the ACPRU.
• Mentor Telemetry Monitor Technicians and Clinical Research Technicians; identifies training needs and conducts training as appropriate.Mentor Telemetry Monitor Technicians and Clinical Research Technicians; identifies training needs and conducts training as appropriate.
• Understands and complies with SOPs, FDA regulations and GCP requirements and identifies potential risks of compliance deficiencies and communicates .Understands and complies with SOPs, FDA regulations and GCP requirements and identifies potential risks of compliance deficiencies and communicates .
• Point of contact for cardiac related instrumentation vendors to ensure ACPRU remains on the cutting edge of cardiac data collection and analysis capabilities.Point of contact for cardiac related instrumentation vendors to ensure ACPRU remains on the cutting edge of cardiac data collection and analysis capabilities.
• Assist with annual enhancement projects for ABBIOS and the data collection system at ACPRUAssist with annual enhancement projects for ABBIOS and the data collection system at ACPRU
• Appropriately/professionally communicate and interact with other ACPRU personnel and study subjects, and other internal/external departments and keeps leadership team abreast of issues as appropriate. • Management of query resolutions for cardiac issues related to ongoing study conduct and closeout of studies. Appropriately/professionally communicate and interact with other ACPRU personnel and study subjects, and other internal/external departments and keeps leadership team abreast of issues as appropriate.
• Management of query resolutions for cardiac issues related to ongoing study conduct and closeout of studies.

Qualifications

• Bachelors Degree Preferred or Associates Degree with equivalent work experience required
• Telemetry monitoring and ECG experience - minimum 6 yearsTelemetry monitoring and ECG experience - minimum 6 years
• Documented proficiency in Cardiac Arrhythmia recognition / high level of ECG experienceDocumented proficiency in Cardiac Arrhythmia recognition / high level of ECG experience
• Phlebotomy background with ECG experience - 6-8 yearsPhlebotomy background with ECG experience - 6-8 years
• Familiarity with medical terminology - 5-7 yearsFamiliarity with medical terminology - 5-7 years
• Clinical research experience - 4-7 years (experience with Phase 1 Healthy Volunteers)Clinical research experience - 4-7 years (experience with Phase 1 Healthy Volunteers)
• Familiarity with GCP documentation requirements - 5-7 yearsFamiliarity with GCP documentation requirements - 5-7 years
• Total combined minimum years of experience - 8 yearsTotal combined minimum years of experience - 8 years

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.