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.