Project Lead, NCI Clinical Trials Monitoring Service

Who We Are

Celebrating 40+ Years! 

 

Theradex Oncology is a full-service CRO, conducting early- and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.   

What You'll Do

Remote- US

 

In this role, you'll serve as Project Manager of the National Cancer Institute Clinical Trials Monitoring Service, lead the National Cancer Institute Cancer Center Site (audit) visits as necessary and serve as Project Manager of the NCI Experimental Therapeutics Clinical Trial Network (ETCTN). In addition, you'll interact with Interact with the NCI Clinical Trials Monitoring Branch (CTMB) Chief and CTMB staff and serve as the primary contact to NCI CTMB, NCI ETCTN DSMB, DSMB members, principal investigators and study statisticians. You'll also interact with other external clients, including but not limited to sponsors, medical monitors, vendors, quality assurance auditors, study Investigators and site representatives.

 

Key Responsibilities

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

 

• As 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
  • Lead team meetings, teleconference, and face to face 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.

 

• As a 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:
  • Provide oversight and support for all functional areas to ensure superior quality deliverables
  • Identify and evaluate risks, interpret data on complex issues, and implement solutions in order to ensure successful completion of trials.
  • Provide oversight to team members for project specific training
  • Review and provide input to new project proposals/contract development
  • Manage and track project conduct
  • Oversee assigned studies and is accountable for all study resultsReview and provide input to new project proposals/contract developmentManage and track project conduct
  • Generate study specific plans and documents
  • Create trial-related training materials for site initiations and ongoing site training
  • Establish and maintaining study timelines
  • Create/Review study status reports and monitoring reports to identify and address possible issues
  • Lead team meetings, teleconference, and face to face meetings
  • Oversee Trial Master File and/or Electronic Study Files
  • Assume other project responsibilities as needed