Job Details

Overview

1. Manages all HVH Research Department operations and staff. Ensures accountability for completion of tasks assigned. Monitors and measures research staff performance. Develops and carries out corrective action plans when necessary. 2. Interprets, supports and communicates policies, standard and procedures of the research process. 3. Ensures all sponsor and regulatory outstanding items are resolved; leads the formulation of corrective action plans for audit deficiencies (responses, quality assurance/audit reports). 4. Leads HVH Clinical Research Department monthly meetings and manages the contents thereof. 5. Responsible for ensuring the HVH Research Department activities are compliant with the Research Integrity Office directives and policies. 6. Responsible for HVH Research Budget and Clinical Trial Agreements. Works collaboratively with the Research Budget Office/Research Contracts Office to ensure that all research related fees are appropriately allocated and clinical trial agreements have been fully executed. 7. Ensures that department, personnel, 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. 8. Assesses staffing requirements of new clinical trials. Communicates staffing, patient care, and safety requirements to budget manager and HVH Administration. 9. 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 and to ensure patient safety. Re-allocates staff to ensure proper completion of each day¿s workload. 10. Creates department based indicators as mandated or necessary, integrating functions of standards development, continuing education, credentialing, performance appraisal, concurrent monitoring, utilization review, risk management, and active problem identification. 11. Analyzes audit findings for trends and provides critical response to study protocol violations. Performs root-cause analyses of violations, develops recommendations for quality improvement, and ensures follow-up and implementation of changes. 12. Represents the research program and serves as ambassador for the HVH in meetings and events with outside research sponsors, partners, and donors. 13. Adheres to the standards identified in the Medical Center's Organizational Competencies.

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Responsibilities

1. Manages all HVH Research Department operations and staff. Ensures accountability for completion of tasks assigned. Monitors and measures research staff performance. Develops and carries out corrective action plans when necessary. 2. Interprets, supports and communicates policies, standard and procedures of the research process. 3. Ensures all sponsor and regulatory outstanding items are resolved; leads the formulation of corrective action plans for audit deficiencies (responses, quality assurance/audit reports). 4. Leads HVH Clinical Research Department monthly meetings and manages the contents thereof. 5. Responsible for ensuring the HVH Research Department activities are compliant with the Research Integrity Office directives and policies. 6. Responsible for HVH Research Budget and Clinical Trial Agreements. Works collaboratively with the Research Budget Office/Research Contracts Office to ensure that all research related fees are appropriately allocated and clinical trial agreements have been fully executed. 7. Ensures that department, personnel, 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. 8. Assesses staffing requirements of new clinical trials. Communicates staffing, patient care, and safety requirements to budget manager and HVH Administration. 9. 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 and to ensure patient safety. Re-allocates staff to ensure proper completion of each day¿s workload. 10. Creates department based indicators as mandated or necessary, integrating functions of standards development, continuing education, credentialing, performance appraisal, concurrent monitoring, utilization review, risk management, and active problem identification. 11. Analyzes audit findings for trends and provides critical response to study protocol violations. Performs root-cause analyses of violations, develops recommendations for quality improvement, and ensures follow-up and implementation of changes. 12. Represents the research program and serves as ambassador for the HVH in meetings and events with outside research sponsors, partners, and donors. 13. Adheres to the standards identified in the Medical Center's Organizational Competencies.

Qualifications

Education, Knowledge, Skills and Abilities Required: 1. Bachelors degree in science, public health, public administration, business or in a related area. 2. Minimum of 10 years of clinical research experience. 3. Working knowledge of FDA and DHHS regulations, Good Clinical Practice Guidelines, CITI, ICH, Safety/IND reporting, Microsoft or similar Office Suite. 4. Excellent speaking, writing, organizational, computer and decision making skills. 5. Must be capable and willing to perform other tasks related to Clinical HVH Research. 6. Mandatory education on human subject¿s research. Education, Knowledge, Skills and Abilities Preferred: 1. Master's degree in nursing, science, public health, public administration, business or in a related area. Licenses and Certifications Required: 1. NJ State Professional Registered Nurse License. 2. Society of Clinical Research Associates Certification or Association for Clinical Research Professionals Certification. Licenses and Certifications Preferred: 1. AHA Basic Health Care Life Support HCP Certification.

Our Network

Hackensack Meridian Health (HMH) is a Mandatory COVID-19 and 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.