Clinical Research Coordinator

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
Working under the direction of the Principal Investigator (PI), responsible for the overall coordination and administration of daily activities of ICR clinical trials. Plays a key role in study conduct and management. Oversees the research process from inception to completion and prepares and organizes the documentation and files pertaining to a study; coordinates the activities of the investigators and the study participants

What you will do 

• 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
• Evaluate new protocols for feasibility with the PI
• Review the protocol and other materials (e.g., Investigator’s Brochure, data collection forms and sample consent forms) for practical procedures, safety issues
• Review study participant eligibility requirements and determining if those participants would be available in sufficient numbers to achieve study enrollment goals
• Assess the logistical requirements and resources necessary to conduct the study
• Prepare site for study conduct
• Prepare documents for submission to the IRB
• Set-up and organize study files
• Train all people involved in the study conduct (e.g., faculty, study staff, ancillary personnel, etc.)
• Collaborating with other departments (e.g.; laboratory, pharmacy, etc.) as indicated
• Attend the investigator start-up meeting
• Schedule and facilitate a site-initiation visit with the study sponsor
• Create or review study-specific source documents
• Collect the documents needed to initiate the study and sending them to the study sponsor
• Participate in for-cause & not-for-cause sponsor, institutional or federal audits
• Participate in the informed consent process as needed
• Work with the sponsor and/or IRB on consent form wording issues
• Obtain translations of the consent forms into other languages, when necessary
• When indicated in the IRB Application, conducting the informed consent process with potential participant (or a potential participant’s authorized legal representative or surrogate)
• Discussing all aspects of study participation
• Reviewing the consent form with the potential study participant
• Answering questions and assessing potential study participant’s comprehension
• Ensuring that all necessary signatures and dates are on the informed consent forms
• Documenting, distributing and filing signed informed consent forms appropriately
• Ensuring that all amended consent forms are appropriately implemented and signed
• Ensuring that the consent process is ongoing and continues throughout the duration of the study
• Manage Study Conduct
• Recruit and screen potential participants
• Work closely with the PI to determine recruitment strategies and manage issues with enrollment; regularly reviews study status/enrollment
• Ensure adherence to the study inclusion/exclusion criteria
• Schedule and manage study participant study visits (e.g., ensuring that all appropriate study procedures are done and documented)
• Manage laboratory procedures (drawing samples, processing, packaging and shipping)
• Review case report form entries for completeness and correctness
• Review case report forms and source documents for adverse events (AE)
• Schedule and facilitate sponsor monitoring visits
• Ensure that test article accountability is done correctly for each study participant and overall
• Other duties as needed

Education Qualifications 

• Bachelor's Degree Bachelor's degree or equivalent experience preferred 
• Master's Degree preferred

Experience Qualifications 

• 1-3 years Min. 1-3 years of experience in coordinating clinical research required and

Knowledge, Skills, and Abilities 

• Analytical mindset, attention to detail, team player, exceptional interpersonal skills, computer skills, organizational skills, verbal and written communication, work with patients, healthcare teams and doctors.

Licenses and Certifications 

• GCP Cert, CCRP, or CCRA preferred preferred