CentraState has an employment opportunity available for a Research Associate. This role administers professional research standards in accordance with hospital policies and in alignment with the guidelines of the National Institutes of Health and the U.S. Food and Drug Administration (FDA). The Research Associate ensures patient safety and protection while maintaining a high level of clinical research quality.

• 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.
• Review 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.
• Assists 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.
• Complete Quality Assurance form for calendars, eligibility checklists and source documents.
• Review records and forms prior to an audit.
• Gather 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.

• 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.

Compensation Range: $35.00 - $59.50 per hour