Research Regulatory Coordinator III

Cooper University Hospital•Camden, NJ

1d•$34 - $56•Onsite

About The Position

Oncology and Research are specialized and require unique skill sets. Realigning the MD Anderson Research Department at Cooper with the MD Anderson Cancer Center at Houston’s recommendation, allows research growth in both the structure and the types of studies we are able to offer our clients to advance care. The regulatory demands of managing the study portfolio requires a lead position in order to oversee regulatory operations and train new staff members.

Requirements

Must have at least 3-5 years of experience.
Experience in clinical research administration that may include regulatory or project management.
Clinical Research Certification

Nice To Haves

More than 5 years of experience strongly preferred.

Responsibilities

Oversees regulatory operations for MD Anderson Cancer Center at Cooper
Participates in the management of the departmental regulatory coordinator and regulatory research assistant staff.
Completes Supervisory skills series offered by Cooper.
Works with the Director of Oncology Research Administration to assign studies to staff and monitors compliance of staff to standards, policies and quality measures.
Coordinates and participates in the interview and selection process.
Manages the cooperative group/federally funded studies including DTLs and regulatory documents
Trains new regulatory staff members
Receive and organize the initial regulatory documents for cooperative group studies
Corresponds directly with sponsors/CTSU via email and by phone
Communicates with colleagues and providers to give updates on study start up for each protocol