Manager - Oncology Regulatory, Clinical Research (Full-Time) - Hackensack Meridian Health

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Manager of Regulatory Clinical Research for Oncology manages the Regulatory Team including the Regulatory Specialists and Initial Submissions Coordinators. Responsible for ongoing development and execution of comprehensive process improvement for all aspects of Oncology Clinical Trial Research Regulatory processes and procedures for the HMH Clinical Cancer Research Department. Ensures and tracks department and clinical trial compliance and performance with Federal Regulations, Good Clinical Practice (GCP) and Institutional policies. Serves as the regulatory liaison between Investigators, research team members, the Institutional Review Board (IRB) and third party vendors. Coordinates, troubleshoots and seek improvement opportunities to the study start-up and on-going regulatory over sight in collaboration with the IRB, Research Integrity Office (RIO) and external regulatory agencies.

A day in the life of a Manager, Oncology Regulatory, Clinical Research at Hackensack Meridian Health includes:

• Manages the Regulatory Specialist team to ensure compliance and proper maintenance of the clinical trial regulatory files and processes.
• Manages the Initial Submission Coordinator team to ensure timely activation of new clinical trials.
• Ensures that all clinical research staff and all research studies are conducted in full compliance with written protocols, SOPs, HUMC Policy, current Good Clinical Practice, IRB policies, Local, State, And Federal regulations, and Joint Commission rules.
• Ensure that all state and federal regulatory requirements are addressed for the clinical research program.
• Manages and engages in the regulatory review, preparation, and submission of clinical study documentation (e.g. investigator brochure, Investigational Device Exemption (IDE), Investigational New Drug (IND), treatment and compassionate/emergent use, etc) as required.
• Manages timeline and accurate submission of all protocol amendments, ICF, Investigator Brochure and other administrative items to the IRB of record.
• Manages the regulatory preparations for monitor visits, audits or site inspections.
• Manages the CTSU application for Clinical Cancer Research Staff and Investigators.
• Acts as liaison between investigators, sponsors and their representative and the IRB on all regulatory issues.
• Leads team meetings and attendance at leadership meetings and conference/in-services as required.
• Provides timely follow-up, issue resolution, update reports and problem escalation as necessary.
• Develop, Implement and Track metric reports to evaluate regulatory compliance and performance according to department needs.
• Orient and train new staff regarding clinical trial regulatory responsibilities.
• Stays abreast of developments in GCP and federal regulations regarding clinical research.
• Maintains overall awareness in the field of clinical research, as well as assigned areas.
• Assists in policy, procedure and workflow development processes.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

• Bachelor's Degree.
• Minimum of 5 years of experience in field or related field.
• Minimum of 3 years of direct Management experience.
• Strong attention to detail and customer service focus.
• Excellent communication, organizational, interpersonal and presentation.
• Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
• Proficiency in Microsoft Office Suite.

• Advanced Degree in research field or related field.
• Proficiency in Google Suite.

• Certified Clinical Research Professional/CCRP
• Certified Clinical Research Associate/CCRA
• Certified Clinical Research Coordinator/CCRC

• Direct contact with but not limited to all Hackensack Meridian Health staff, study sponsors and designees, third party auditors and FDA inspectors.

If you feel the above description speaks directly to your strengths and capabilities, then please apply today!