Clinical Research Coordinator IV, Department of Internal Medicine - Cardiology (Phoenix)

Study Start Up:

• Participate in evaluation of new clinical research protocol requests to assess feasibility of proposed study resource allocation and clinical needs.
• Serve as the primary resource to investigators, sponsors, clinical research staff and collaborators for clinical research conduct of complex and multi-center studies.
• Collaborate on planning, designing, and reviewing study specific budget and documentation needs, coordinator effort and hospital resources; establishing priorities and recommending schedules, timetables and costs.
• Assist compliance team with IRB submissions, amendments, and regulatory documents.

Clinical Trial Coordination:

• Assists with protocol and budget review of potential sponsored projects related to departmental initiatives.
• Serve as liaison to sponsor/CRO for study start up and regulatory needs.
• Maintain source file for ongoing departmental clinical research activities to ensure progress with subject enrollments, data and reporting requirements.
• Coordinate patient screening, recruitment, consent, visit and procedure scheduling, patient monitoring and follow per protocol requirements.
• Collect and process specimens to meet study requirements per protocol.
• Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.
• Participate in local and national collaborative calls related to program operations.
• Ensure quality and timely submission of data across studies.
• Provide project reports and other documentation throughout the project life cycle.
• Proactively take initiative to ensure enrollment stays on track with the project timelines and develop additional recruitment strategies to ensure successful enrollment into the study.

Oversight and Reporting:

• Maintenance and reporting of departmental study portfolios by PI and divisions.
• Oversight of study specific team tasks including accurate screening, enrollment processes, data collection and reporting.
• Identify and coordinate multidisciplinary team(s) to support coordinator needs and address challenges for study implementation in a timely manner.
• Facilitate completion of study team trainings, ensure compliance with regulatory requirements and billing processes.
• Provide guidance to research personnel and support staff; coach and mentor study team to build knowledge and skills; create learning opportunities for employees.

Collaborations and Communications:

• Serve as liaison between COM-P clinical research administration, Banner hospital and community partners and mentors.
• Regular review of regulatory compliance and metrics reporting and alignment of departmental research efforts to those of the College.
• Periodic review and recommendations to update COM-P specific study related charges to ensure adequate coverage of ongoing resource costs.
• Ensure completion of investigator trainings, compliance reporting and evaluation.
• Timely identification of obstacles and potential solutions for successful success.
• Effective collaboration to ensure progress in enrollment milestones and study completion.
• Assist other members by educating, providing resources and consulting on difficult protocols or projects.

Compliance and education:

• Responsible for ensuring compliance with federal regulations for human subject research, University policies, and Sponsor expectations as well as for continuing education relevant to their role.
• Maintaining current human subject research training, attending relevant educational seminars, and professional development in clinical research operations.
• Supports the orientation and training of new research team members, including faculty, residents/fellows, and other staff.

Knowledge, Skills, and Abilities:

• Skilled in troubleshooting and critical thinking to resolve issues in clinical research settings.
• Able to multitask and prioritize in high-pressure environments.
• Self-motivated with a strong ability to work independently.
• Flexible schedule to support patient enrollment and follow-up in critical care studies.
• Ability to handle complex or high-risk patient interactions with empathy and professionalism.
• Skilled in Leadership and Team Collaboration: Ability to train, mentor, and supervise junior coordinators and research assistants.
• Strong communication skills for collaborating with physicians, study sponsors, and other stakeholders.
• Time Management and Organizational Skills.