Associate Director Clinical Research Operations

Company: Vitalief Inc.
Location: New Brunswick
Posted on: May 5, 2022

Job Description:

Overview
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 remote weekly.

Responsibilities:
Directs and manages a portfolio of clinical trials within GI and GU, overseeing a team of 3 managers and overall staff of 25 people.
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 data management.
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 expertise.
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.

Required Skills:
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 agency.
3 or more years of experience in a supervisory role; strong leadership and team building skills, and ability to engage their managers.
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, and PowerPoint.
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 hire.
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 plus.

If interested in finding out more about opportunities with Vitalief, please contact:

Glenn Murani
Director of Talent Acquisition
Vitalief
610-209-1083
glenn@vitalief.com
vitalief.com

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