Manager, Clinical Research, Department of Obstetrics & Gynecology (College of Medicine - Phoenix)

The selected individuals will work closely with UA and hospital partners to troubleshoot issues through protocol development, 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 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.

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; state retirement plan; 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.

Collaborations and Communications:

• Serve as liaison between Division Managers, COM-P clinical research administration, hospital and community partners and mentors
• Work closely with COM-P Senior Director of Clinical Research to ensure regulatory compliance and metrics reporting, and to align departmental research efforts to those of the College.
• Periodic review and make 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 study completion.
• Collaborate effectively with others to ensure proper progress in enrollment milestones and completion of studies
• 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 oversight of the clinical research activities for outpatient and inpatient study needs
• 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 the development and conduct of scholarly research projects.
• Oversight for the preparation, review, submission, timelines and maintenance of regulatory activities/submissions to the IRB.
• Ensure accuracy and timeliness of distributing regulatory updates to all collaborative parties.
• Work closely with the Department Chair and Research Director and serve as liaison with external partners to orchestrate projects annually.
• Manage all operational and administrative aspect of the projects from following up with academic partners, contracts, budgets to logistic management.
• Assist in events associated with 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 as they relate to departmental initiatives.
• Serve as liaison to sponsor/CRO for study start up and regulatory needs.
• 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 of data submitted and assure timely submission of data
• Maintain master files for clinical research protocols.
• 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:

• Critical thinking and troubleshooting skills.
• Ability to multitask and be self-motivated.

• Bachelor's degree or equivalent advanced learning attained through professional level experience required.
• Minimum of three (3) years of related work experience or equivalent combination of education and work experience required.

College of Medicine-Phoenix, Office of Human Resources

HR-PHX@arizona.edu

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

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