Clinical Research Manager II, Department of Neurosurgery (Phoenix)

The Departments of Neurosurgery, Neurology and Surgery at the College of Medicine - Phoenix are collaborating to grow their research and are seeking a Manager, Clinical Research for the administration and oversight of each department's growing clinical research portfolio. The incumbent will report to the Sr. Director of Clinical Research and the Department Chairs to provide day to day operational, regulatory and supervisory support for numerous clinical research initiatives to ensure successful implementation of and adherence to research protocols and milestones regarding planning, administration, timeline management, scheduling of coordinators, enrollment, participant engagement, data collection, and reporting. This position will manage coordination and administration of department and IRB approved initiatives including federal and industry sponsored studies.

The selected individual will work closely with UA and hospital partners to troubleshoot issues through all phases of protocol approval, as well as provide oversight of study status and milestones, training and supervision and allocation of efforts of clinical research coordinators who are involved in regulatory review, enrollment, informed consent, study procedures, data collection and documentation, and interactions with the study team and clinical partners. The Manager, Clinical Research will demonstrate competence and leadership in clinical research skills, problem solving, critical thinking, multitasking, priority setting and serve as a resource for others for all aspects of conducting clinical research and clinical program evaluations.

The University of Arizona College of Medicine - Phoenix anchors the 28-acre Phoenix Bioscience Core in the heart of the Valley of the Sun. The College inspires and trains individuals to become exemplary physicians, scientists and leaders who are life-long learners and inquisitive scholars. The Phoenix Biomedical Campus embodies the University's priorities of engagement, partnership, innovation, and synergy in its world-class academic and research initiatives, with clinical facilities throughout Greater Phoenix.

Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; retirement plans; access to UA recreation and cultural activities; and more!

The University of Arizona has been recognized for our innovative work-life programs. For more information about working at the University of Arizona and relocations services, please click here.

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.
• Assist in the planning, designing, and review of study specific budget and documentation needs, coordinator effort and hospital resources. establishing priorities and recommending schedules, timetables and costs.
• Oversee department clinical research submission process for new studies, facilitating research determination, interdisciplinary reviews and status tracking of department study portfolio in regulatory review.
• Assist compliance team with IRB submissions, amendments, and regulatory documents.
• 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.
• Assist in the planning, designing, and review of study specific budget and documentation needs, coordinator effort and hospital resources. establishing priorities and recommending schedules, timetables and costs.
• Oversee department clinical research submission process for new studies, facilitating research determination, interdisciplinary reviews and status tracking of department study portfolio in regulatory review.
• Assist compliance team with IRB submissions, amendments, and regulatory documents.

Collaborations and Communications:

• Serve as liaison between Department Chair, COM-P clinical research administration, 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.

Oversight and Reporting:

• Maintenance and reporting of departmental study portfolios by PI and divisions.
• Provide day to day operational oversight of the departmental research activities.
• Supervision of personnel including recruitment, assignments, training, administering performance appraisals and disciplinary actions.
• Identify and coordinate multidisciplinary team(s) to support coordinator needs and address challenges for study implementation in a timely manner.
• Determine coordinator placement on upcoming studies, facilitate completion of trainings, ensure compliance with regulatory requirements and billing processes,
• Ongoing assessment of personnel workload, expectations, and goals through regular review of data integrity and study performance, developing applicable corrective action plans as needed.
• Provide career development guidance to research personnel and support staff; coach and mentor staff to build knowledge and skills; create learning opportunities for employees.
• Make job requirements and goals for each position clear to employees and provide sufficient training to achieve the desired level of competency; document evidence of competence on a continuing basis.

Scholarly Project Management:

• Provide guidance for implementation and conduct of scholarly research projects including timelines for IRB preparation, review, submission processes. maintenance of regulatory activities/submissions to the IRB.
• Tracking and reporting of departmental scholarly activity, providing status updates to mentors and collaborative parties.
• Work closely with the Department and Research Directors and serve as liaison with external partners to orchestrate projects annually.
• Manage operational and administrative aspects of approved projects that require academic partnership, contracts, budgets and logistical management.
• Collaborate with residency and fellowship leadership to organize annual scholarly project presentations.
• Work with internal stakeholders to identify potential partners needed for successful conduct of for academic projects.

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 master file for ongoing departmental clinical research activities to ensure progress with subject enrollments, data and reporting requirements.
• Coordinate patient screening, recruitment, consent, visit scheduling, patient monitoring and follow per protocol guidelines.
• 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.
• Provides project reports and other documentation throughout the project lifecycle.
• Proactively take initiative to ensure enrollment stays on track with the project timelines.

Knowledge, Skills, and Abilities:

• Ability to troubleshoot and problem solve
• Critical thinking skills
• Ability to multitask and self-motivate

• Bachelor's degree or equivalent advanced learning attained through professional level experience required.
• Minimum of 5 years of related work experience, including 2 years of managerial experience, or equivalent combination of education and work experience.

• Master's Degree in Health Sciences or related field.
• Previous experience in academic research.
• Certified Clinical Research Professional (CCRP).

Application: The online application should be completed in its entirety. Blank or missed information may be considered an incomplete submission.

Cover Letter: Should clearly indicate how your skills and professional employment experience meet the Minimum and the Preferred qualifications (if applicable).