Clinical Research Coordinator (onsite)

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 studyCompleting IRB required human subjects protection training (in addition to any other sponsor required training)Complying with all IRB decisions, conditions and requirementsCapturing and reporting adverse events and protocol violations to the study PI, the IRB and the study sponsorEnsuring that PHI will not be reused or disclosed to any parties other than those described in the IRB-approved protocol, except as required by lawMaking 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 wayEvaluate new protocols for feasibility with the PIReview the protocol and other materials (e.g., Investigators Brochure, data collection forms and sample consent forms) for practical procedures, safety issuesReview study participant eligibility requirements and determining if those participants would be available in sufficient numbers to achieve study enrollment goalsAssess the logistical requirements and resources necessary to conduct the studyPrepare site for study conductPrepare documents for submission to the IRBSet-up and organize study filesTrain 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 indicatedAttend the investigator start-up meetingSchedule and facilitate a site-initiation visit with the study sponsorCreate or review study-specific source documentsCollect the documents needed to initiate the study and sending them to the study sponsorParticipate in for-cause & not-for-cause sponsor, institutional or federal auditsParticipate in the informed consent process as neededWork with the sponsor and/or IRB on consent form wording issuesObtain translations of the consent forms into other languages, when necessaryWhen indicated in the IRB Application, conducting the informed consent process with potential participant (or a potential participants authorized legal representative or surrogate)Discussing all aspects of study participationReviewing the consent form with the potential study participantAnswering questions and assessing potential study participants comprehensionEnsuring that all necessary signatures and dates are on the informed consent formsDocumenting, distributing and filing signed informed consent forms appropriatelyEnsuring that all amended consent forms are appropriately implemented and signedEnsuring that the consent process is ongoing and continues throughout the duration of the studyManage Study ConductRecruit and screen potential participantsWork closely with the PI to determine recruitment strategies and manage issues with enrollment; regularly reviews study status/enrollmentEnsure adherence to the study inclusion/exclusion criteriaSchedule 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 correctnessReview case report forms and source documents for adverse events (AE)Schedule and facilitate sponsor monitoring visitsEnsure that test article accountability is done correctly for each study participant and overallOther duties as needed

Education Qualifications

Bachelor's Degree Bachelor's degree or equivalent experience preferredMaster'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