Assistant Director, Clinical Research Operations

Department

BSD MED - Hematology and Oncology - Clinical Research Administration

About the Department

The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.

Job Summary

The Assistant Director supports the Director of Clinical Research Operations in developing strategy, training, and establishing standards and best practices for our oncology clinical trial portfolio. The trial portfolios includes industry studies, multi-site investigator-initiated studies, single-site investigator-initiated studies, and National Clinical Trial Network (NCTN) studies. This position will be responsible for ensuring Cancer Center wide compliance with our local Institutional Review Board (IRB), National Cancer Institute (NCI) guidelines, Good Clinical Practice (GCP) and FDA Regulations. Additionally, this position will oversee the Cellular Therapy clinical research program including the recruitment, placement, and management of the clinical research coordinators and expansion into non-oncology indications. This role will also work with the other hematological malignancies Clinical Research Managers and provide dedicated support to aid them in the execution of projects and tasks centered on increasing enrollments, increasing earnings, and overall protocol compliance. The position will work closely with Director of Clinical Operations on various project and initiatives to improve our overall clinical research operations and will assist with the roll out and maintenance of various new systems and software. The Assistant Director will collaborate and liaise with leadership within the Cancer Center, University Research Administration (URA), Office of Clinical Research (OCR), and Institutional Review Board (IRB) as well as Program Directors, Clinical Research Managers, faculty and other key constituents throughout the University and network as needed.

The position reports to the Section of Hematology/Oncology.

Responsibilities

• Assist with the implementation of new software and technology systems that impact overall clinical research operations (i.e. Clinical Trial Management System and Tumor Response System).

• Define strategy and create a roadmap on how to leverage key systems such as EPIC, REDCap, Oncore, & Florence eRegulatory to optimize workflows.

• Supervise and support the clinical research coordinators within the Cellular Therapy program and ensure they are operating in compliance with their assigned protocols and our Standard Operating Procedures (SOP).

• In collaboration with faculty aid in the selection of new clinical trials and lead first stage review discussions and aid in documentation collection for trials being submitted for initial institutional review.

• Setup processes and required infrastructure to support cellular therapy trials in non-oncology indications.

• Project manage trials within the study start-up pipeline for Cellular Therapy.

• Review and manage trial priorities from a coordinator perspective and align staff based on disease, workload, sponsor databases, trial type, or therapeutic drugs.

• Oversee the development and maintenance of relevant data management Standard Operating Procedures (SOPs) and instructions related to clinical research operations for all trial types.

• Support and oversee the hematological malignancies clinical research managers.

• Lead the in-patient clinical research committee.

• Liaise with Quality Research Manager and internal monitor on creating any required corrective action and preventative action plans.

• Work with the Clinical Trials Financial Group (CTFG) to ensure sponsors are appropriately invoiced.

• Serve as subject matter expert on clinical research best practices and industry trends.

• Manages and directs the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.

• Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.

• Performs other related work as needed.

Minimum Qualifications

Education:

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