Director, Member Scientist Clinical Research

Overview

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 Director, Member Scientist, Clinical Research is responsible for initiating, leading and undertaking clinical research projects, generating reports and publications based on research findings.

This role develops and implements a plan to build a research infrastructure inclusive of implementing a recruitment plan as well as the developing a research plan to ensure Hackensack Meridian Health is positioned appropriately to respond to national grant opportunities including but not limited to submission of the TBI Model Systems application and related pilot projects in acquired brain injury rehabilitation.

Responsibilities include maintenance, revision and renewal of all required institutional agreements related to the conduct of human subjects research, insuring operational review or procedures prior to study approval, engaging and fostering research relationships and partnerships, encouraging growth and professional development in team members in pursuit of research opportunities, participating in grant contracts and associated projects, providing grant mandated audits, budgets and reports, and overseeing all aspects of research operations administration.

This is an on-site position.

Responsibilities

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

• Possesses the necessary skills to assess scientific merit of all rehabilitation related clinical research proposed to the institution through the use of statistical analyses, research design and methodology and overall clinical value in research in collaboration with the appropriate leadership, principal investigators and grant applications.
• Identifies new topics and develops and obtains funding for proposals (including academic, private and public sector funders) supporting relevant clinical research projects in rehabilitation medicine / acquired brain injury and neuropsychological / neurobehavioral health;

assists other team members in obtaining funding for future projects.

• Serves as a high-level resource for NIDLRR, NIH, FDA, OHRP, CMS and / or any other pertinent regulations pertaining to human subjects research.
• Plans and evaluates strategies to develop immediate and long term goals to continually improve the research process within the established guidelines of Hackensack Meridian Health.
• Maintains and executes IRB Reciprocity Agreements and Single Use Authorizations in support of multi-institutional and collaborative research studies.
• Manages the Research Study Review and Approval Process, including assessment of all study-related documents and coordinates with research financial personnel for the development of study budgets.
• Reviews and certifies all consent and lay summaries submitted to the Institutional Review Board for approval.
• Ensures that the study operational review process is thorough and in accordance with Hackensack Meridian Health guidelines and established practices.
• Resolves unique and complex research study issues; works with investigators and Hackensack Meridian Health team members to find feasible and safe operational plans.
• Participates in and supports audits. When necessary, corresponds with federal agencies with the concurrence of Hackensack Meridian Health Legal office.
• Oversees the research credentialing process for all applicants and ensures timely completion of the credentialing process
• Directs and monitors the new protocol submission process to assure timely submissions.
• Directs and monitors patient accrual to clinical trials in accordance with established grants and the objectives of Hackensack Meridian Health.
• Creates budgets for all clinical trials and manages appropriate distribution of fees to various participating departments and principal investigators.
• Produces high quality reports, papers and articles of a publishable standard based on the analysis of data and literature with a clear and engaging writing style.
• Responsible for the recruitment and job performance of research staff. Identifies and recommends the need for appropriate disciplinary action up to and including termination.
• Responsible for all regulatory compliance in accordance with federal and institutional guidelines in the conduction of clinical research, oversees and responds to audits and reports findings.

Provides and implements corrective action plan when appropriate.

Responsible for establishing pipeline relationships with outside / private companies to negotiate research budgets and contracts in accordance with Hackensack Meridian Health policy.

These relationships assure the provision of novel therapies for the patient population serviced.

• Responsible for fiscal reports and analyses discussing any discrepancies.
• Acts as a liaison in matters related to research to enhance local, regional and national recognition.
• Provides continuing education programs for medical staff, nursing, therapists, department leaders and research staff to increase knowledge and assure compliance with regulatory guidelines.
• Promotes quality participant care and customer service / satisfaction, while promoting safety, cost efficiency and a commitment to the performance improvement process.
• Maintains academic and hospital appointments to support and advance research efforts.
• Facilitates data abstraction requests in concert with the Information Systems Department.
• Other duties and / or projects as assigned.
• Adheres to Hackensack Meridian Health Organizational competencies and standards of behavior.

Qualifications

Education, Knowledge, Skills and Abilities Required :

• PhD from an accredited graduate level institution in a medical, healthcare or scientific field.
• Minimum of 10 or more years experience in clinical healthcare.
• Minimum of 8 or more years of experience in clinical research.
• Evidence of progressively increasing levels of responsibility, specifically for organization- wide clinical research programs.
• Knowledge of relevant clinical research and human subject regulations and guidelines including but not limited to FDA,NIH, NIDLRR,CMSS, OHRP, DOD and HIPAA.
• Able to interpret regulations for appropriate operational implementation for all types of research studies; retrospective chart reviews, observational, registry, interventional, IND, IDE or Expanded Access (Compassionate Use).
• Demonstrates excellent ability to discern and protect confidential information; skilled in diplomacy and problem resolution at a high level;

capable of discerning when supervisor must be consulted to resolve a compliance issue

• Excellent organizational, team building and partnership-building skills.
• Sophisticated approaches to identifying and addressing institutional risk concerns and issues. Ability to discern organizational key stakeholders in resolving risk issues.
• Excellent written and verbal communication skills.
• Proficient computer skills that may include but are not limited to Microsoft Office and / or Google Suite platforms.

Licenses and Certifications Preferred :

PhD from an accredited graduate level institution in a medical, healthcare or scientific field.

Experience in neuropsychology / rehabilitation preferred.

Society of Clinical Research Associates Certification or Certified Clinical Research Administrator or Certified Clinical Research Professional.

Licenses and Certifications Required :

SOCRA-Certified Clinical Research Professional (CCRP) and / or Certified Clinical Research Associate (CCRA) and / or Certified Clinical Research Coordinator (CCRC).

Licenses and Certifications Preferred :

• Board Certification
• State Licensure

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