Manager, Clinical Research Center Operations

Hackensack Meridian Health•Neptune City, NJ

18h

About The Position

The Center for Discovery and Innovation- CDI was established by Hackensack Meridian Health (HMH) as an academic basic and translational research enterprise to rapidly translate science innovation to the clinic and to improve outcomes for patients with cancer, infectious diseases, autoimmune disease and other acute and chronic diseases. The CDI has grown rapidly since its origins in 2019, and now has 39 labs, 200+ scientists and allied personnel supported by 78 NIH and DoD grants and more than 87 other grants and contracts. Areas of expertise include genomics, epigenetics, drug resistance, stem cell biology, drug discovery, diagnostics and biomarker development, rheumatology and pharmacology. The Manager, Clinical Research Center Operations is responsible for Clinical Research Center Staff and other clinical support staff for all areas of Clinical Research across the Hackensack Meridian Health (HMH) network, ensuring compliance of all research studies and regulations. A day in the life of a Manager, Clinical Research Center Operations at Hackensack Meridian Health includes:

Requirements

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.

Nice To Haves

1 years of supervisory experience.
1 years with clinical research management experience.

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.