Clinical Research Assistant - Full Time | Days

Description

Holy Name is New Jersey's last remaining independent, Catholic health system, comprising a comprehensive 361-bed acute care medical center, a cancer center, medical fitness center, residential hospice, nursing school, and physician network.

The system has a national reputation for providing culturally sensitive care to a diverse population, drawing patients from across the New York City region to its specialty centers and renowned doctors.

Holy Name's mission to provide technologically advanced, compassionate and personalized care extends across a continuum that encompasses education, prevention, diagnosis, treatment, rehabilitation and wellness maintenance.

The system is known as a high-quality, low-cost provider of extraordinary clinical care given by compassionate, highly trained physicians and staff.

A Brief Overview

The Clinical Research Assistant manages various projects for both administrative and clinical research components of the Institute for Clinical Research.

Oversees special projects and programs, monitors progress and produces reports for the Directors of the ICR. Leads and encourages staff to reach goals and deadlines.

What you will do

• Administrative Responsibilities
• Works on special projects as needed to include but not limited to :
• Manages new software systems training, implementation and ongoing maintenance
• Manages communications; works with Holy Name marketing on social media on internal / external publicity and ICR websites
• Manages database development; dashboards and reporting
• Assist in development of Policies and SOPs
• Coordinates meetings and manages Executive Director’s schedule
• Clinical Study Responsibilities
• Assist with study start-up
• Study budgets
• Clinical Trial Agreements
• Regulatory requirements
• Assist with post-award activities
• Study financials, closeouts and coordination
• Work with PI and study team to evaluate new protocols for feasibility
• Prepare site for study conduct
• Participate in informed consent process as needed
• Manage study conduct
• Protect the rights and welfare of human subjects in clinical research
• Understanding the regulatory, institutional, sponsor and protocol requirements for the study
• Completing IRB required human subjects protection training (in addition to any other sponsor required training)
• Complying with all IRB decisions, conditions and requirements
• Capturing and reporting adverse events and protocol violations to the study PI, the IRB and the study sponsor
• Ensuring that PHI will not be reused or disclosed to any parties other than those described in the IRB-approved protocol, except as required by law
• Making sure that all studies have current IRB approvals before any study is initiated, continued beyond the period of current approval (usually 1 or 3 years) or modified in any way

Education Qualifications

Bachelor's Degree or equivalent work experience required

Experience Qualifications

3 years experience in research or clinical setting required

Knowledge, Skills, and Abilities

• Knowledge of patient rights and laws relative to those rights, such as HIPAA
• Excellent communication skills both written and verbal
• Good organizational and interpersonal skills
• Ability to build comprehensive reports and effectively convey information to others.

Holy Name is a mission-driven facility whose quality standards and philosophy are rooted in the principles of its founders, the Sisters of St.

Joseph of Peace. Those principles are exercised daily by the Medical Center's dedicated and talented team of physicians, nurses, allied health employees, and a wide variety of non-clinical administrative and operational staff members.

Holy Name is an Equal Opportunity Employer.