Job Summary and Responsibilities: The Dir, Research is responsible for the clinical operation of all research conducted in The Hackensack Meridian Health Network in accordance with federal and institutional guidelines.
1. Directs and monitors the new protocol submission process to assure timely submissions.
2. Directs and monitors patient accrual to clinical trials in accordance with established grants and the objectives of The HMH Network.
3. Oversees the contract process for clinical trials and assures 90 day or less turn around.
4. Oversee budgets for all clinical trials and grants and manages appropriate distribution of fees to various participating departments and principal investigators.
5. Responsible for the recruitment and job performance of all research staff. Identifies need for appropriate disciplinary action up to and including termination making recommendations to the VP of Research.
6. Plans and evaluates strategies to develop immediate and long term goals to continually improve the research process within the network.
7. Responsible for all regulatory compliance in accordance with federal (e.g. FDA, NCI) and institutional guidelines in the conduction of clinical research. Directs audits and reports findings. Provides and implements corrective action plan when appropriate.
8. Responsible for establishing pipeline relationships with pharmaceutical companies to negotiate research budgets and contracts in accordance with Hackensack Meridian Health Network vision. These relationships assure the provision of novel therapies for the patient population serviced at Hackensack Meridian Health Network.
9. Responsible for fiscal reports and analyses discussing any discrepancies with the VP of Research and Regulatory Affairs. Manages the patient billing process through continual assessment of study budget accuracy, data entries on drug study accounts (DSA) and reconciliation of daily billing to assure compliance.
10. Establishes measures to maintain quality with control patient billing.
11. Possess the necessary skills to assess scientific merit of all clinical trials proposed to the institution through the use of statistical analyses, research methodology and overall clinical value in research in collaboration with the Vice President and principal investigator.
12. Acts as a liaison for The HMH Network in matters related to oncology research to enhance local, regional, and national recognition.
13. Manages continuing education programs for medical staff, nursing and data managers to increase knowledge and assure compliance with regulatory guidelines.
14. Responsible for the development and implementation of all policies and procedures required for the clinical operation of the department.
15. Adheres to the standards identified in the Organizational & Managerial Competencies.
Education, Knowledge, Skills and Abilities Required:
1. Bachelor's degree.
2. Minimum of 3 years of experience in any bioscience field.
Education, Knowledge, Skills and Abilities Preferred:
1. Master's or Ph.D. level preferred.
2. Oncology experience preferred.
Job ID 20755