Associate Director Clinical Research Operations
Company: Vitalief Inc.
Location: New Brunswick
Posted on: May 5, 2022
Vitalief is a fast growing, "best of breed" Clinical Trial
Solutions Company. We are currently seeking a talented Associate
Director Clinical Research Operations to join our exceptional team,
that has a passion for establishing credibility with our clients by
supporting 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: Work location is New Brunswick, four days on-site & one day
Directs and manages a portfolio of clinical trials within GI and
GU, overseeing a team of 3 managers and overall staff of 25
Areas of responsibility include Research Nursing Services, Clinical
Research Coordinator Services, and Clinical Trial Navigation.
Provides supervision to research staff to assist in improving the
effectiveness and efficiency of clinical research coordination and
Works with leadership to define performance objectives and accrual
metrics for each Disease Specific Group.
Assures that all clinical research conducted within our client's
organization is in accordance to Good Clinical Practice (GCP)
guidelines as well as applicable Institutional, State and Federal
regulations and guidelines.
Organizes the clinical research area to ensure there is adequate
space for examination, diagnostic study and treatment of patients;
makes recommendations as appropriate.
Responsible for the administrative oversight of all clinical
research patient care delivery systems consistent with our client's
standards and monitors quality of patient care for all subjects
enrolled to clinical trials.
Develops and coaches staff/other disciplines to work as a team;
establishes collaborative relationship with Investigators.
Recruits/selects/hires/evaluates and recommends disciplinary and
personnel actions for all clinical and business support staff.
Leads the patient care team in providing the "best care" in the
"most economical" way while ensuring patient and staff safety.
According to protocol guidelines, recruits and interviews human
subjects for research studies, when requested.
Ensures Serious Adverse Events (SAEs) are completed and reported to
the QA Manager and sponsor if necessary within reporting deadlines
outlined in the protocol.
Serves as a role model, mentor and resource for the Managers,
Research Nurse Clinicians and Clinical Research Coordinators.
Identifies and develops areas of nursing and clinical research
Conducts regular Quality Assurance audits of nursing documentation
to verify completeness, accuracy and to ensure that the research
project, database or protocol is carried out as outlined.
Facilitates Change: Identifies areas for performance improvement
and engages research staff in improvement projects.
Maintains working knowledge of DHHS, FDA, OHRP, NIH, GCP, HIPAA,
IRB and other applicable guidelines. Reviews all applicable
guidelines and incorporates information into daily workplace.
Maintains SOCRA CCRP or ACRP CCRC certification.
5 or more years of clinical research nursing experience required,
preferably in an ambulatory care setting.
3 years of experience in review and evaluation of budget,
organization, administrative practices, computer applications in a
large health care or education environment or government
3 or more years of experience in a supervisory role; strong
leadership and team building skills, and ability to engage their
Effective oral and communication skills.
Must be computer literate with proficiency and working knowledge of
database and reporting tools such as Microsoft Word, Excel, Access,
American Heart Association: BLS required.
Oncology Nursing Certification (OCN) and Association of Clinical
Research Professional (CCRC) or Society of Clinical Research
Associates (CCRP) certification required within 2 years of
Bachelor's Degree in Nursing with a license to practice as a
registered nurse in the State if NJ.
Master's Degree in Nursing, Health Care Administration, Public
Health, Administration, or a related field is preferred.
Any experience managing labor in a unionized environment is a
If interested in finding out more about opportunities with
Vitalief, please contact:
Director of Talent Acquisition
Keywords: Vitalief Inc., New Brunswick , Associate Director Clinical Research Operations, Healthcare , New Brunswick, New Jersey
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