Project Lead, NCI Clinical Trials Monitoring Service

Who We Are Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

What You'll DoAs part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

We are seeking an oncology research professional with 6+ years experience within an academic clinical oncology, pharmaceutical industry, or CRO environment. To be considered you must hold either a PharmD or Doctor of Medicine (MD) from an accredited institution.

Experience with clinical trials sponsored by the NCI is preferred. In this role, you'll serve as Project Manager of the National Cancer Institute Clinical Trials Monitoring Service, overseeing cancer center audit visits, and serve as Project Manager of the NCI Experimental Therapeutics Clinical Trial Network (ETCTN). You'll be the primary contact for the NCI Clinical Trials Monitoring Branch, NCI members, interacting with principal investigators, study statisticians, sponsors, medical monitors, vendors, auditors, and site representatives.

Key Responsibilities The primary responsibilities of this position include, but are not limited to, the following:

Project Manager of the NCI CTMS is responsible for operational aspects of the CTMS monitoring and auditing, which includes but is not limited to:

Provide oversight of NCI CTMS Clinical Research Associates (i.e., monitors) from an operational perspective and lead team meetings

Select patient cases for all CTMS ETCTN monitoring visits

Review all NCI CTMS site visit reports

Review all corrective and preventive action plans provided by cancer centers in response to CTMS data audits, annual and cancer center site visits.

Lead the conduct and reporting of selected NCI CTMS audits in accordance with NCI Experimental Therapeutics Clinical Trial Network (ETCTN) guidelines

Maintain and continuously analyze cancer center performance metrics for discussion with NCI Clinical Trials Monitoring Branch (CTMB) leadership.

Write the monitoring and site performance content of NCI CTMS semi-annual progress reports and other reports as required.

Review of the eligibility criteria for new EDC study builds.

Provide administrative support to the NCI ETCTN Data and Safety Monitoring Board (DSMB) through collaboration with CTMB, development and review of DSMB operating procedures and charter, follow the progress of all studies overseen by the DSMB, alert internal and external stakeholders of anticipated meetings, work with Theradex Oncology statistical programming and data management in preparation of meetings, prepare status reports for DSMB members, organize and deliver training on DSMB procedures to study investigators and study statisticians, prepare DSMB meeting minutes and follow up letters.

Senior Project Manager, this role is responsible for leading both technical and operational aspects of each project to ensure compliance with FDA regulations and Theradex procedures.  Other responsibilities include but are not limited to:

Oversee all functional areas to ensure high-quality deliverables and lead team meetings

Identify risks and complex issues, interpret data, and implement solutions to complete trials successfully

Provide oversight to team members for project specific training

Review and provide feedback on new project proposals and contracts

Manage and track project conduct

Oversee assigned studies and is accountable for all study results

Manage and track project progress

Generate study specific plans and documents

Create trial-related training materials for site initiations and ongoing site training

Establish and maintain study timelines

Create and review study and monitoring reports to identify and address issues

Oversee Trial Master File and/or Electronic Study Files Supervision of Investigational Product Storage and Distribution Team…