Research Associate

Overview

CentraState Healthcare System, headquartered in Freehold, New Jersey, is a leading nonprofit healthcare provider dedicated to serving the community. Its comprehensive network includes CentraState Medical Center, a community-focused hospital, an ambulatory campus, two senior living facilities, three free-standing community health pavilions, and a charitable foundation. As the third-largest employer in Monmouth County, CentraState has earned repeated recognition as a Great Place to Work-Certified™ company, reinforcing its reputation as an exceptional workplace. CentraState has an employment opportunity available for a Research Associate.

Responsibilities

• Responsible for all IRB processes (local, central or partner facility).
• Participates in site feasibility and protocol activation meetings.
• Ascertains that there is documented Institutional Review Board (IRB) approval for protocols prior to activation meeting.
• Actively participates in selection of appropriate patients for study in collaboration with physician.
• Administers patient evaluation and assessment tests as appropriate.
• Completes the pre-study work including preparation of internal study binder, source document development and case report form development if necessary.
• Develops the calendar for the protocol.
• Participates in protocol activation meetings.
• Ascertains that pretreatment and eligibility of the protocol have been met including a completed informed consent obtained prior to registration.
• Responsible for the patient receiving a signed copy of the consent form.
• Abstracts data from various sources to retrieve the necessary information to complete eligibility checklists, pre-study flow sheets, pathology reports, etc to confirm patient eligibility.
• Reviews pre-study information to confirm eligibility and register the patient.
• Documents the patient registration in the database.
• Places patient name and calendar in the internal study binder.
• Reviews protocol enrollment forms for patients entered onto trials by affiliate investigators, reviews copies of eligibility test results provided by affiliate investigators, and confirms eligibility prior to protocol initiation.
• Reinforces explanations of clinical trials to patients, significant others and personnel.
• Affords assistance in the reporting of adverse events and completion of required forms.
• Maintains current knowledge of protocols, eligibility requirements, and amendments.
• Completes pharmaceutical company Case Report Forms and cooperative group flow sheets.
• Maintains active and follow up list of patients.
• Obtains data from outside sources (physician offices/hospitals) as needed for data collection and submission.
• Obtains all data information from affiliate centers.
• Ensures that they are following the protocols correctly.
• Provides them with a calendar to follow.
• Maintains, updates records on protocol patients.
• Prepares a follow-up calendar for the appropriate protocols.
• Obtains and submits x-rays, operative/pathology report, or other specialized reports as needed.
• Submits pathology or other lab materials and appropriate forms when required.
• Notifies the appropriate physician, staff, and the Director of Pharmacy of all serious adverse events (SAE).
• Compiles all necessary forms related to SAE's.
• Completes and submits all follow-up forms for cooperative groups and pharmaceutical clinical trials.
• Acts as a resource to all personnel to assist in maintaining protocol compliance re study calendar dose modifications, etc.
• Maintains all protocol related items organized, including patient charts, shadow charts and Case Report Forms.
• Participates in all necessary meetings required for the specific tumor study group.
• Acts as liaison with sponsor organization and pharmaceutical companies coordinating research studies.
• Attends and participates in clinical research meetings.
• Evaluates protocol study forms for completeness, accuracy and compliance to protocol.
• Completes Quality Assurance form for calendars, eligibility checklists and source documents.
• Review records and forms prior to an audit.
• Gathers records, reports, radiographs, scans and other necessary materials required at the time of site visits by cooperative groups, pharmaceutical companies, or the FDA.
• Communicates effectively with staff and others.
• Anticipates and responds to the needs of others, providing assistance in a courteous quick manner.
• Assists in the promotion of team work.
• Responds appropriately to incoming communications.
• Consistently abides by the Food and Drug Administration (FDA) and IRB policies and procedures.

Qualifications

• Bachelor's degree in related healthcare field required.
• Previous experience in clinical research preferred.
• Research Certification through Association of Clinical Research Professionals or Society of Clinical Research Professionals required.
• Strong professional, organizational, and interpersonal skills to effectively relate with all members of the healthcare team.