Director, Clinical Research Operations

Company: Vitalief Inc.
Location: New Brunswick
Posted on: June 20, 2022

Job Description:

OverviewVitalief is a fast growing, "best of breed" Clinical Trial Solutions Company. We are currently seeking a talented and ambitious leader to join our exceptional team as the Director, Clinical Research Operations. This person will have a passion for establishing credibility with our clients by supporting the research staff in the planning and execution of successful clinical trials. Every trial is different and requires a solution that will optimize outcomes. Our approach explores innovative ways of delivering services in a distributed model that can support both decentralized and centralized trials.If you are interested in being part of a culture that includes the ability to have a voice challenging the status quo with novel thinking, flexible work environment, transparent and open communications, career pathing, and a variable incentive / reward system, then we want to speak with you!Note: This role is 4 days per week on-site in New Brunswick, NJ; and one day per week remote. Responsibilities:

• Providing proactive leadership and oversee all aspects of clinical research operations. Focusing on innovation, program improvement, quality, safety, efficiency, and growth. Developing both short-term and long-term plans for growth and expansion of existing services; as well as, for the introduction of new programs. Fostering collaborative relations with a wide range of academic and private research organizations to enhance organizational research endeavors.
• Assuring that all clinical research conducted is according to Good Clinical Practice (GCP) guidelines as well as applicable Institutional, State and Federal regulations and guidelines. Areas of responsibility include Research Nursing Services, Clinical Research Coordinator Services, Data Management Services, and Clinical Trial Lab Services
• Directing all clinical research operations and endeavors, keeping executive management informed of trends and changes.
• Utilizing situational leadership principles to assist staff in performing roles independently while providing constructive feedback and recognition for accomplishments. Working with leadership to define performance objectives and accrual metrics for each Disease Specific Group (DSG). Developing and coaching staff to work as a team; establishing collaborative relationship with Investigators.
• Supporting the patient care mission while implementing patient centered processes and monitoring for quality of care. Developing new approaches to increasing patient accruals to clinical trials and supporting change.
• Recruiting/selecting/hiring/evaluating and recommending disciplinary and personnel actions for all clinical and business support staff.
• Workforce planning to ensure adequate research staff to meet patient and department needs, while holding staff members accountable for their responsibilities and productivity expectations.
• Mentoring, coaching, and managing staff. Utilizing appropriate disciplinary measures, counsels, and advises staff, as necessary.
• Creatively recruiting new employees and implementing innovative retention efforts.
• Maintaining departmental culture where employees are encouraged, reinforced, and supported in their desire to contribute.
• Assuring compliance with Institutional, State and Federal regulatory agencies for all clinical trials. Participating in the implementation of strategies to meet all regulatory requirements and investigating all reported protocol deviations and creating/reviewing all corrective action plans.
• Following all applicable policies and procedures related to clinical research billing and promoting the prevention, detection, and resolution of instances of non-compliance with billing policies and procedures.
• Preparing, evaluating, analyzing, and presenting Accrual/Billing/Financial Volume reports while monitoring for variance. Actively working to reduce costs and assure cost effectiveness of services (+/- 5%) and efficiency (productivity at least 90%).
• Training and development of research staff by serving as a role model, mentor, and resource for clinical research personnel.
• Provide supervision to assist in improving the effectiveness and efficiency of clinical research coordination and data management. Participate in the training and orientation of the newly hired staff.
• Coordinate with the research staff in preparing and providing protocol specific educational in-services to clinic, research and hospital staff as required.
• Work collaboratively to implement professional development and orientation initiatives for clinical research staff. Participate as expert educator for nursing and patient education programs.
• Monitoring and assuring the training and competency of all clinical research staff. Complete performance evaluations annually on time and evaluate staff competency utilizing random research chart audits; observations; testing, etc.
• Conducting Quality Assurance audits of documentation to verify completeness and accuracy. Review audits to ensure that deviations are being reported and corrective action plans implemented and distributed as appropriate. Create, execute, and evaluate the Performance Improvement Plan/Program
• Keeps abreast of all pertinent federal, state and regulations, law, and policies as they presently exist and as they change or are modified. Maintains working knowledge of DHHS, FDA (Food and Drug Administration), OHRP (Office for Human Research Protection), NIH (National Institutes of Health), GCP, HIPPA, IRB (Institutional Review Board) and other applicable guidelines. Reviews all applicable guidelines and incorporates information into the daily workplace.Required Skills:
  • Master's Degree in Nursing, Health Care Administration, Public Health, Business Administration, or a related field.
  • 5+ years of advanced leadership experience in scientific academic health care, preferably in oncology.
  • Demonstrated experience leading clinical research operations in a complex organization, including interfacing effectively with multiple faculty and staff with a strong customer service focus.
  • Must have interventional clinical research experience.
  • Must have strong leadership skills and experiencing leading manager and associate director staff members. This position will oversee approximately a staff of 85 team members.
  • Ability to think strategically and apply broad concepts in practice.
  • Work collaboratively with stakeholders across the institution.
  • Prior experience implementing large organizational initiatives preferred.
  • Must have excellent communication and interpersonal skills including the ability to present, facilitate, negotiate, and interact with individuals at all levels within the organization.
  • Flexibility and ability to adapt to changing environment is essential. If interested in finding out more about opportunities with Vitalief, please contact:Glenn MuraniDirector of Talent AcquisitionVitalief610-209-1083glenn@vitalief.comvitalief.com

Keywords: Vitalief Inc., New Brunswick , Director, Clinical Research Operations, Executive , New Brunswick, New Jersey