What are the responsibilities and job description for the MANAGER - ONCOLOGY REGULATORY, CLINICAL RESEARCH (FULL-TIME) position at JFK Johnson Rehabilitation Institute?
Manager - Oncology Regulatory, Clinical Research (Full-Time)
HACKENSACK UNIVERSITY MED CNTR Hackensack, New Jersey
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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.
Responsibilities
A day in the life of a Manager, Oncology Regulatory, Clinical Research at Hackensack Meridian Health includes:
Education, Knowledge, Skills and Abilities Required:
HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER
All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
Our Network
Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility
As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.
Apply
Share
See the area you’ll be working in and get an idea of what your daily routine around the office can be like. Learn More
Awards We’ve Received
2023
US News & World Report 2023
US News & World Report 2023
US News & World Report 2023
2023
2023 & 2022 Magnet Designations
for 9 HMH Institutions
2022
Newsweek 2022 Best Hospitals USA
Newsweek 2022 America’s Best Addiction Treatment Centers
Blake Recovery Center at Carrier Clinic - #2
2023
Diversity Inc. 2023
Top Hospital and Health Systems
2022
Becker’s Hospital Review 2022
At Hackensack Meridian Health, we help our patients live better, healthier lives – and we help one another succeed. Here, competitive benefits are just the beginning. It’s also about how our team members support one another and how we show up for our community. Together, we’re ready to transform health care and advance our mission to serve as a leader of positive change.
Join us and let’s keep getting better together.
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HACKENSACK UNIVERSITY MED CNTR Hackensack, New Jersey
Apply
- Requisition # 2025-159418
- ShiftDay
- StatusFull Time with Benefits
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.
Responsibilities
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.
Education, Knowledge, Skills and Abilities Required:
- 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.
HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER
All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
Our Network
Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility
As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.
Apply
Share
- X
- LinkedIn
See the area you’ll be working in and get an idea of what your daily routine around the office can be like. Learn More
Awards We’ve Received
2023
US News & World Report 2023
- HUMC - #1 Hospital in NJ & #5 in NY Metro Area
US News & World Report 2023
- Joseph M. Sanzari Children’s Hospital - #1 Children’s Hospital in NJ
US News & World Report 2023
- JSUMC - #6 Hospital in NJ
2023
2023 & 2022 Magnet Designations
for 9 HMH Institutions
2022
Newsweek 2022 Best Hospitals USA
- HUMC - #57
Newsweek 2022 America’s Best Addiction Treatment Centers
Blake Recovery Center at Carrier Clinic - #2
2023
Diversity Inc. 2023
Top Hospital and Health Systems
2022
Becker’s Hospital Review 2022
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At Hackensack Meridian Health, we help our patients live better, healthier lives – and we help one another succeed. Here, competitive benefits are just the beginning. It’s also about how our team members support one another and how we show up for our community. Together, we’re ready to transform health care and advance our mission to serve as a leader of positive change.
Join us and let’s keep getting better together.
STAY CONNECTED
From roles that are right for you to new opportunities, join our talent community and stay up to date with job openings and more.
SIGN UP
