Director, Clinical Research Operations
Company: Vitalief Inc.
Location: New Brunswick
Posted on: June 20, 2022
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
- 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
- Workforce planning to ensure adequate research staff to meet
patient and department needs, while holding staff members
accountable for their responsibilities and productivity
- Mentoring, coaching, and managing staff. Utilizing appropriate
disciplinary measures, counsels, and advises staff, as
- Creatively recruiting new employees and implementing innovative
- Maintaining departmental culture where employees are
encouraged, reinforced, and supported in their desire to
- 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
- 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
- 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
- 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
- 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
- Work collaboratively with stakeholders across the
- Prior experience implementing large organizational initiatives
- Must have excellent communication and interpersonal skills
including the ability to present, facilitate, negotiate, and
interact with individuals at all levels within the
- 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
Keywords: Vitalief Inc., New Brunswick , Director, Clinical Research Operations, Executive , New Brunswick, New Jersey
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