Manager, Clinical Research Operations-Neuroscience

Location

Hackensack, NJ | United States

Job description

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, Clinical Research Ops is responsible for the Clinical Coordinators, Clinical Data Coordinators, Regulatory Staff and other clinical support staff for all areas of Clinical Research across the HMH network, ensuring compliance of all research studies and regulations.

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

• Manages the Clinical Coordinators, Clinical Data Coordinators, Regulatory 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 team members in PeopleSoft HR system.
• Evaluates, develops and implements corrective action plans for team members.
• 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 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.
• Manages departmental research budgets.
• Complete, oversee and monitor all regulatory activity
• Will ensure research staff members adhere to SOPs

Education, Knowledge, Skills and Abilities Required:

• Bachelor's degree and 6 years of clinical research experience; or 10 years of progressive clinical research experience.
• Working knowledge of FDA and DHHS regulations, Good Clinical Practice Guidelines, CITI and Safety/IND reporting.
• Proficient computer skills in platforms such as, but not limited to, Microsoft Office Suite, Google, etc.
• Excellent speaking, writing, organizational, computer and decision making skills.
• Must be capable and willing to perform other tasks related to Clinical Research.
• Mandatory education on human subjects research.

Education, Knowledge, Skills and Abilities Preferred:

• 5 years of supervisory experience.
• 3 years with clinical research management experience. 

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

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