Hackensack Meridian Health · 3 hours ago
Manager, Clinical Research Center Operations
Neptune City, NJ
Full-time
Onsite
Mid, Senior Level
$112K/yr - $112K/yr
6+ years expHackensack Meridian Health is an academic basic and translational research enterprise focused on improving patient outcomes through innovative research. The Manager, Clinical Research Center Operations is responsible for overseeing clinical research staff, ensuring compliance with research studies, and managing operational decisions related to clinical trials across the HMH network.
Assisted LivingHealth CareHealth DiagnosticsHospitalMedical
Responsibilities
Manages Clinical Research staff and other clinical trial support staff, assigns schedules and makes operational decisions regarding staffing levels, workflow, and coverage for clinical trials research
Monitors and measures staff performance regularly and performs all evaluations
Interprets, supports and communicates policies, standards and procedures of the research process
Provides training of all new team members and assigns coverage for multiple research locations
Ensures that staffing on clinical trials is maintained at agreed upon service level in study protocol, in study budget and in accordance with SOPs to ensure cost effective use of Department resources
Manages hiring and payroll processes for HMHN Research team members in PeopleSoft HR system
Evaluates, develops and implements corrective action plans with research team members
In the absence of the director, leads research department weekly meetings and attends monthly meetings for all areas that Research supports
Ensures that team members are in full compliance with written protocols, SOPs, HMH policy and GCP, IRB policies, FDA regulations, HMHN Continuing Education and license requirements and Joint Commission rules
Protocol management for Phase I, II, III and IV study operations for the network research activity and interacts with ancillary Medical Center staff (Pharmacy, Laboratory, Infusion Center, etc) for the proper execution of a protocol
Liaison with Principal Investigators and leads study feasibility and provides support to new PIs beginning the research process
Meets with FDA auditors and sponsor representatives as required
Reviews correspondences from sponsors and regulatory authorities (monitoring follow up letters, quality assurance) to ensure all outstanding items are resolved
Works closely with staff and department to ensure corrective action plans for audit deficiencies are resolved
Works collaboratively with the Research Budget/Contracts office to ensure that research related fees are appropriately captured and that trial agreements are fully executed
Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of Standard Operating Procedures
Attends educational offerings and conferences to stay current on best practices
Other duties and/or projects as assigned
Adheres to HMH Organizational competencies and standards of behavior
Qualification
Required
Bachelor's degree in nursing or other relevant area of study
Minimum of 6 or more years of experience in clinical research experience
Working knowledge of FDA and DHHS regulations, Good Clinical Practice Guidelines, CITI and Safety/IND reporting
Excellent organizational and decision-making skills
Must be capable and willing to perform other tasks related to Clinical Research
Mandatory education on human subject's research
Excellent written and verbal communication skills
Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms
Preferred
1 years of supervisory experience
1 years with clinical research management experience
Benefits
Health
Dental
Vision
Paid leave
Tuition reimbursement
Retirement benefits
Company
Hackensack Meridian Health
Hackensack Meridian Health is a health care organization that offers research and medical services.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$36.3MKey Investors
Baldrick's FoundationNational Institutes of Health
2023-11-21Grant
2023-02-24Grant· $3M
2019-05-10Grant· $33.3M
Leadership Team
Robert C. Garrett
Chief Executive Officer
Michael Allen
President, Financial Services Division and CFO
Recent News
bloomberglaw.com
2026-01-20
2025-12-15
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