Project Manager, Clinical Research Development

Description - External

The Project Manager, Clinical Research Development in the Office of Clinical Research (OCR) will work closely with the multidisciplinary clinical and scientific investigators to support the development, submission, and management of Fox Chase Investigator Sponsored and Initiated clinical trials. Responsibilities include, but not limited to accurate preparation and submission of Fox Chase Investigator Sponsored clinical research protocols and related documents to the Scientific Research Review Committee and Institutional Review Board ,in accordance with policies and regulations. The Clin Res Dev PM will assist with writing and developing new protocols and data collection tools; compile, submit, and oversee FDA submissions; complete submissions and clarifications requested by the Clinical Trials Reporting Program and clinicaltrials.gov; and support the analysis and publication of results. Responsible for overseeing the study project life cycle, managing direct reports within the Clinical Research Protocol Development team and delegating tasks to other team members as appropriate. Certifications required within one year of hire.

Education
Masters Degree (Required)
Doctorate Degree (Preferred)
Combination of relevant education and experience may be considered in lieu of degree.

Experience
2 Years experience in developing clinical research protocols and project management (Required)
4 Years experience in research or related field, preferably in clinical trials or lab-based research (Required)
2 Years experience submitting IND/IDEs to the FDA (Required)
4 Years experience in oncology research (Preferred)

License/Certifications
ACRP-CP - Assn Clin Res Prof - Cert Prof (Required) or CCRP - Cert Clin Research Prof (Required)
PMP - Project Management Prof (Preferred)