Research Coordinator – (Community Oncology) – Altoona
Altoona, PAFull-time
Behavioral Health Market Context
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Job Description
s needed. This is a unique role allowing for the clinical research professional to work in the community with research studies in many cancer disease centers with UPMC Hillman Cancer Center as a Clinical Research Coordinator. The Clinical Research Services (CRS) team is made up of nearly 200 staff members who facilitate the development, implementation, coordination, internal data monitoring, and completion of oncology‑focused trials at Hillman. These trials include institutional (investigator‑initiated), multi‑center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry‑sponsored trials. Using a disease‑specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study‑specific training, data collection, and specimen collection and processing. The Research Coordinator role assists with all aspects of patient care throughout the clinical trial process, which includes tasks such as obtaining informed consent of the patient, hosting patient visits, assessing patients in clinic, recording adverse events, updating medication logs and assisting the physician‑investigator in confirming dose reductions and treatment parameters per protocol guidelines. The RC is responsible to ensure adequate documentation of all research visits in OnCore in real time, to ensure fiscal teams are able to process charges appropriately and in a timely manner. Responsibilities Assists in data collection, data entry and quality control of data. Follows appropriate research policies and procedures including all applicable laws, regulations, and department policies while maintaining scientific integrity and protocol compliance. Pre‑screen and recruit subjects for ongoing and new research studies, perform consent with appropriate documentation of research process. Coordinate non‑complex clinical visits per research protocol requirements (including but not limited to drug assignment release, follow up visits for cell therapy, Level 6 or below visits, SAE and AE form completion, and follow up for inpatient visits). Effectively communicate with critical research personnel and external departments if any subject safety related issue that requires medical assessment. Collect, document, complete and submit non‑serious and serious adverse event reports and/or follow ups, including obtaining medical records and concomitant drug reconciliations associated with those events. Attend and participate in routine study and coordinating center calls. Assist with preparation of audits/monitoring visits and conduct timely review of audit/monitoring visit reports. Review protocol to confirm dose modifications are completed as required including obtaining sponsor and investigator confirmation/clarification. #J-18808-Ljbffr
Qualifications
Benefits
Responsibilities
- •Using a disease‑specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study‑specific training, data collection, and specimen collection and processing
- •The Research Coordinator role assists with all aspects of patient care throughout the clinical trial process, which includes tasks such as obtaining informed consent of the patient, hosting patient visits, assessing patients in clinic, recording adverse events, updating medication logs and assisting the physician‑investigator in confirming dose reductions and treatment parameters per protocol guidelines
- •The RC is responsible to ensure adequate documentation of all research visits in OnCore in real time, to ensure fiscal teams are able to process charges appropriately and in a timely manner
- •Responsibilities Assists in data collection, data entry and quality control of data
- •Follows appropriate research policies and procedures including all applicable laws, regulations, and department policies while maintaining scientific integrity and protocol compliance
- •Pre‑screen and recruit subjects for ongoing and new research studies, perform consent with appropriate documentation of research process
- •Coordinate non‑complex clinical visits per research protocol requirements (including but not limited to drug assignment release, follow up visits for cell therapy, Level 6 or below visits, SAE and AE form completion, and follow up for inpatient visits)
- •Effectively communicate with critical research personnel and external departments if any subject safety related issue that requires medical assessment
- •Collect, document, complete and submit non‑serious and serious adverse event reports and/or follow ups, including obtaining medical records and concomitant drug reconciliations associated with those events
- •Attend and participate in routine study and coordinating center calls
- •Assist with preparation of audits/monitoring visits and conduct timely review of audit/monitoring visit reports
- •Review protocol to confirm dose modifications are completed as required including obtaining sponsor and investigator confirmation/clarification
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