Clinical Research Program Manager

Job Number
201717
Banner Alzheimer's Institute
Shift
Day
Department
Banner Alzheimer's Institute - Image Analysis Laboratory-Fed
Position Type
FT: Full-Time
Street Address
1111 East McDowell Rd
City & State
US-AZ-Phoenix
Posting Category
Research
New Grad
Yes

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Banner Alzheimer's Institute is currently seeking a Clinical Research Program Manager.  This position is located in Central Phoenix, just east of 7th Street & McDowell.

 

The Alzheimer's Disease Core Center (ADCC) is an NIH funded program that consists of seven member institutions: Arizona State University, the Barrow Neurological Institute, the Mayo Clinic Arizona, the Banner Sun Health Research Institute, the Translational Genomics Research Institute (TGen), the University of Arizona, and Banner Alzheimer’s Institute. Significant amounts of data are collected at each site from participants enrolled in longitudinal clinical trials which include demographics, family history, medications, health history, neuropsychiatric inventory and testing and clinical diagnoses. This results in the collection of over 1000 distinct data elements at each annual visit which are recorded in a centralized Electronic Data Capture (EDC) system. The data points are subsequently extracted from the EDC and uploaded to the National Alzheimer’s Coordinating Center (NACC) where extensive data quality and validation rules are applied and exception reports are generated.

 

The incumbent will be responsible for coordinating with each participating site to ensure timely data entry, resolution of exceptions generated by NACC, hosting an annual meeting of all sites to discuss best practices, working with the Information Technology team to further enhance the EDC system and participating in national and local consortium meetings. We are seeking a candidate with excellent communication and organizational skills with an ability to learn the details of the data collected from these clinical trials and subject area of Alzheimer’s research.

 

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About Banner Alzheimer's Institute
BAI was established in 2006 as Banner Health's first Center of Excellence. Banner Health is one of the largest nonprofit health care systems in the United States. Our team is uniquely, passionately and strategically committed to ending Alzheimer's without losing another generation and to providing an unparalleled model of care for families facing this devastating disease. BAI is committed to improving people's lives through excellent patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's research and care.

 

Truven-2013
Stage7-2013

About Banner Health
Banner Health is one of the largest, nonprofit health care systems in the country and the leading nonprofit provider of hospital services in all the communities we serve. Throughout our network of hospitals, primary care health centers, research centers, labs, physician practices and more, our skilled and compassionate professionals use the latest technology to change the way care is provided. The many locations, career opportunities, and benefits offered at Banner Health help to make the Banner Journey unique and fulfilling for every employee.

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Job Summary

This position will assist in the development and successful execution of clinical trials for which Banner serves as a sponsor, from protocol concept through clinical study report. This position will coordinate efforts of cross-functional project teams to support milestone achievement.

 

Essential Functions

  • Coordinates study activities to support milestone achievement and to manage study issues and obstacles. Supports the communication plans by creating communication materials; updating documentation and web sites.

 

  • Assists in the development of study-related documentation, including clinical research study protocols, informed consent forms, case report forms, monitoring plans, data management plans, statistical analysis plans, and IRB/IEC submissions and renewals.

 

  • Facilitates project meetings and coordinates the interaction with other departments and stakeholder groups.

 

  • Organizes and manages project timelines, milestones, and critical study activities to ensure project deliverables are on time and within budget. Provides regular updates to leadership as appropriate.

 

  • Coordinates problem solving and resolution efforts to include management of risk, contingencies and issues.

 

  • Facilitates project closure including identifying lessons learned; effectively incorporating lessons learned into future projects; successful transition from project to production for all aspects and team members; appropriately manages project documentation.

 

  • Adheres to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Banner policies and procedures.

 

 

Minimum Qualifications

Bachelor's degree in life / health sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience.

Strong organization and documentation skillsExcellent communication and interpersonal skills

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, ProjectManager)Working knowledge applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP)

Preferred Qualifications

Masters Degree preferred.

Additional related education and/or experience preferred.