Manager, Clinical Research Jobs in Hackensack at Hackensack Meridian Health

Overview

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Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Manager, Clinical Research is responsible for Clinical Data Coordinators and other clinical support staff for all phases of the data collection for the Clinical Cancer Research Department ensuring compliance to all regulatory regulations.

Responsibilities

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

• Manages Clinical Data Coordinators, Diagnostic Technicians, and other clinical trial support staff: schedules assignments and makes operational decisions regarding staffing levels, workflow, coverage, etc.
• Holds staff accountable for completion of assigned tasks including weekly and monthly reports to CCRD and Cancer Center upper management.
• Monitors and measures research staff performance on a daily basis which also includes annual evaluations.
• Participates in the hiring and terminating of the Clinical Data Coordinators and support staff.
• Responsible for the evaluation, developing, and implementing corrective action measures for the Clinical Data Coordinators.
• Ensures that department, all staff, and all research studies are in full compliance with written protocols, SOPs, HUMC Policy, current Good Clinical Practice, IRB policies, FDA regulations, and Joint Commission rules.
• Ensures that staffing on clinical trials is maintained at agreed upon service level in study protocol, in study budget, and in accordance with department SOPs, to ensure cost effective use of resources.
• Re-allocates staff if necessary to ensure proper completion of each day's workload. Based on the collaborative analysis of data, develops plans for improvement and coverage.
• Protocol management: Phase I, II, III, and IV laboratory operations for the Clinical Cancer Research Department up to and including designating CCRD staff and interacting with Medical Center Staff for the purpose of proper execution of a protocol.
• Responsible for orientation and training of new Clinical Data Coordinators in collaboration with the research nursing educator.
• Meets with FDA auditors and sponsor representatives as required.
• Maintains and approves Clairvia staff schedules and all managerial People Soft related activities.
• 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 on special projects for Clinical Cancer Research Department quality assurance, regulatory affairs and education sections, including submission of standard operating procedures (SOP) for Data Management and Phase I, II, II, IV laboratory procedures.
• Attends educational offerings and conferences to stay current on best practices.
• Adheres to HUMC and Departmental organizational and managerial competency requirements.
• Reports directly to Director Clinical Cancer Research.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• Bachelor's degree in the sciences.
• Minimum of 3 years of supervisory experience.
• Minimum of 3 years of basic science lab work experience.
• Minimum of 3 years of cancer clinical trial data management experience.
• Excellent computer and analytical skills (Excel and Word).

Education, Knowledge, Skills and Abilities Preferred:

• Master's Degree in the sciences.
• Minimum of 5 years of supervisory experience.

Licenses and Certifications Required:

• Society of Clinical Research Associates Certification or Association for Clinical Research Professionals Certification OR must earn certification within (1) year of hire.

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

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.