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Manager, Clinical Research Core, BADER Consortium

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  • Manager, Clinical Research Core, BADER Consortium

    THIS IS A GRANT FUNDED POSITION LOCATED IN NEWARK, DELAWARE. CONTINUATION IS CONTINGENT UPON CONTINUED FUNDING.

    The BADER Consortium is a 5-year (started October 2011), $19.7 million Department of Defense cooperative agreement between the Congressionally Designated Medical Research Program (CDMRP), Peer Reviewed Orthopaedic Research Program (PRORP) and the University of Delaware. As the heartbeat of the BADER Consortium, the Clinical Research Core (CRC) will support the conduct of numerous multi-site clinical research trials across a broad array of North American sites. These sites include Military Treatment Facilities (MTFs) in California, Texas, Virginia and Maryland. The CRC will do this by instituting a uniform and sustainable research infrastructure that will facilitate ongoing and new clinical research trials across all MTF and additional government and civilian research sites.

    Under limited direction of the Consortium Director and with oversight by the Director of Research, the Manager works independently to achieve broadly stated objectives. The Clinical Research Manager will develop and oversee the CRC, up to ten employees and all clinical research support activities of the BADER Consortium. Reporting to the Director of the BADER Consortium, the Clinical Research Manager will serve as a subject expert being responsible for independently establishing policies, goals and objectives for the CRC’s uniform clinical research protocol management structure, training, and research support activities. This includes, but is not limited to, implementing a Protocol Data Management System (PDMS) and training staff to use the PDMS, modeling protocols on the PDMS, tracking progress of research studies at Department of Defense Medical Treatment Facilities (MTFs) and other clinical research sites, developing policies and procedures and supervision of off-site personnel. The Clinical Research Manager is responsible for establishing and implementing policies for the handling and protection of confidential and sensitive data. The Clinical Research Manager routinely interacts with senior management at MTFs and other clinical sites. The work involves a considerable amount of variety and complexity of data, information, resources, regulations, sources and technical requirements.
    This is a grant-funded position; continuation is contingent upon continued funding. Notice of non-renewal is not required. The successful candidate will have a temporary (renewable based upon continued external funding) appointment in the College of Health Sciences, Department of Kinesiology and Applied Physiology, fully funded by the BADER Consortium.

    MAJOR RESPONSIBILITIES:

    • Responsible for the coordination and oversight of the clinical research support activities under the Clinical Research Core which is the primary interface between the Clinical Coordinating Center and the MTFs and clinical research sites across all proposed and future sites. Supervises up to ten support staff under a unique structure.

    • Oversees all aspects of the PDMS for the BADER Consortium. Responsible for seeking the broadest possible implementation and management of the PDMS. Interfaces with software developer and IT staff to diagnose and correct problems. Provides guidance and support of

    BADER Consortium, University of Delaware, 5 Innovation Way, Suite 300, Newark, Delaware 19711
    biospecimen repository PDMS function. Develops policies and procedures around PDMS. Modeling of Consortium-wide research protocols into the PDMS and trains research staff in utilization of PDMS modules.

    • Monitor and report all adverse events, protocol deviations or unexpected problems to BADER Consortium Director of Research who will determine how event is to be handled. Monitor all regulatory compliance for research studies. Evaluation of research study progress through individual project principal investigators provided progress reports.

    • Designs and develops Consortium-wide forms, questionnaires and database systems for collection and processing and retrieval of study data.

    • Train MTF staff on how to use and model protocols into the PDMS and monitors for accuracy once entered. Oversight and management of the training in research methods, human subject’s protections, and scientific procedures for BADER supported researchers and staff.

    • Development and implementation of reporting tools to support the Director of the BADER Consortium, Director of Research, PIs, and authorized MTF leadership.

    • Oversees timely completion by PIs and research staff of analysis of data and preparation of manuscripts for publications, grant submissions or reports.

    • Develops policies and procedures relating to modeling of research protocols across all MTFs and clinical study sites. Facilitates the design of BADER-Consortium wide standard operating procedures to ensure compliance with regulatory standards for data collection and documentation and compliance with HIPAA policies and procedures for authorization and use of protected health information. Monitors multi-site IRB clearance at multiple levels.

    • Designs and models essential BADER Consortium-wide regulatory and administrative documents. Facilitates universal implementation of document usage across all MTFs and clinical study sites.

    QUALIFICATIONS:

    • Master’s degree in a healthcare-related field with a minimum of three years of administrative experience in a leadership/supervisory position.

    • Experience in the design and implementation of multi-site clinical research support structures, clinical administration and/or clinical documentation preferred.

    • Experience and extensive knowledge, skills and abilities with multi-site clinical data management policies and procedures preferred.

    • Knowledge of IRB regulations including experience with multi-site IRB administration preferred.

    • Experience with clinical trials preferred.

    • CITI certification is strongly preferred.

    • Strong ability to work collaboratively and in partnership with academe, government and industry leadership.

    • Evidence of interpersonal skills to work effectively with remotely located staff and collaborative partners.

    • Documented ability to learn and use data management and productivity software quickly and independently.

    • Demonstrated human resources skills to manage a unique personnel structure.

    • Strategic planning and problem solving skills highly desired.

    • Ability to develop, plan and implement short and long range goals and objectives.

    • Proven track record working in an environment requiring accurate record keeping of extensive clinical data or experimental data.

    • Ability to use advanced techniques in spreadsheet, database, and/or presentation software.

    • Ability to communicate and interact well with people of all ages and diverse backgrounds.

    SALARY AND BENEFITS: Competitive and commensurate with experience and qualifications. Professionals at the University have regularly received annual cost-of-living and merit salary increases and the benefits package is one of the best in the nation, supporting inclusion of UD in the Chronicle of Higher Education's "Great Colleges to Work For" program for the past 3 years.

    REVIEW OF APPLICATIONS: Applications are accepted until position is filled. Review of applications will begin on January 21, 2012. Nominations and expressions of interest will be held in confidence and references will not be contacted without the candidate's permission. Applicants must submit a letter of application and resume to http://www.udel.edu/udjobs/. Please combine cover letter and resume into one document. For inquiries, contact: Rachel Strickland, Search Committee Chair, 302-831-7267, rs@udel.edu
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