• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $75,000 - $85,000

Position Summary

The Assistant Regulatory Manager will be responsible for assisting the Regulatory Manager with the overall management of regulatory functions performed across all disease groups within the Clinical Protocol & Data Management (CPDM) Office. With oversight from the Regulatory Manager, the Assistant Regulatory Manager may manage a small subset of Regulatory staff as direct reports.

The position demands a mastery-level understanding of local, federal, and international regulations. An advanced level understanding of regulatory submission processes, inclusive but not limited to those of OHRP, FDA, ICH-GCP, local/central IRBs, and external industry partners/Sponsors is expected. Trial types within the office include retrospective/prospective research with protocols that are industry/externally Sponsored, National Cancer Institute (NCI) (i.e., SWOG, NRG, Alliance) Sponsored, and Investigator-Sponsored IITs. This position reports directly to the Regulatory Manager.

This position is located at 400 Kelby St. Fort Lee, NJ.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

Responsibilities include, but are not limited to:

STAFFING/SUPERVISION/TRAINING

• Assists Regulatory Manger with the coordination regulatory activities of the CPDM. Provides supervision to a subset of Regulatory staff members.
• Conducts recurring, department-wide regulatory trainings to promote regulatory compliance, patient safety, and excellence
• Works with Regulatory Manager to monitor workload assignments and develop quality control mechanisms.
• Participates in the screening and interview process of new Regulatory Coordinators. Ensures that new staff are on-boarded and complete regulatory, university, and departmental trainings.
• With oversight from Regulatory Manager, participates in annual staff performance reviews for direct reports.

MONITORING/AUDIT

• Directs routine sponsor audit preparations and federal inspections. Assists assigned regulatory coordinators by conducting Pre-Audit monitoring of the regulatory binder.

DEPARTMENT INITIATIVES

• Assists the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs).
• Implements processes that improve, streamline, and stimulate the work environment, ensuring and promoting positive relationships and outcomes with internal Columbia offices and external agencies.
• Assist with special projects as assigned.

REGULATORY STARTUP, MAINTENANCE, CLOSURE

• The incumbent may manage small subset of clinical research studies and ensure that all regulatory activities are completed in a timely and confidential manner.
• Collaborates with the clinical team to ensure timely submission of new protocols, renewals, modifications, and other regulatory functions.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's Degree or equivalent plus three years of related experience

Preferred Qualifications

• Experience in the clinical research setting, including a thorough understanding of ICH-GCP and CFR guidelines.
• Excellent interpersonal and organizational skills.
• Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
• Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA.