Research Coordinator

divh2Research Coordinator/h2pRound Rock, United States of America | Full time | Office-based/ppThe Research Coordinator advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care. Research Coordinators assist with screening patients, schedule, and oversee all on-study requirements. Research Coordinators attend study teleconferences with sponsors and clinical research organizations to assure continuity of information./ppEssential Duties and Responsibilities/ppEssential and other important responsibilities and duties may include but are not limited to the following:/pulliProtocol Compliance/liulliIdentifies primary and secondary study objectives and outcome measures/liliAdheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research/liliComplies with NEXT Oncology SOPs/liliParticipates in providing timely, informative, and accurate communication with the interdisciplinary team to ensure protocol compliance and timelines of protocol-related procedures/liliCollaborates with the Principal Investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs/liliProvides protocol specific education to clinical staff/liliFacilitates and participates in the preparation for an conduct of meetings/teleconferences with sponsors, monitors, and auditors/liliProvides timely, accurate, and complete reporting of serious adverse events, unanticipated problems, deviations, violations, and noncompliance to the IRB and sponsor/liliContributes to the development of corrective and preventive action plans for unanticipated problems, deviations, violations, and issues of noncompliance/li/ulliInformed Consent/liulliIdentifies and intervenes to address barriers to effective informed consent discussions and decision making (e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception)/liliDescribes and abides by institutional policy and processes for informed consent/liliEnsures that the most current version of the IRB approved protocol consent document is used by the physician investigator when consenting or re-consenting a patient/liliCollaborates with the physician investigator to ensure initial and ongoing consent process is performed and documented/liliAssesses ongoing consent through discussions with patients and reinforcement of education/liliAssesses patients understanding of the information provided during the informed consent process/liliEnsures timely re-consenting as needed by the physician investigator/liliDemonstrates understanding of tiered consent process when optional correlative studies (e.g., biospecimen, quality of life, patient-reported outcomes collections) are involved/liliConfirms informed consent is obtained prior to performing any study specific tasks/li/ulliManagement of Clinical Trial Patients/liulliCollaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol/liliEducates the patient and family regarding protocol participation/liliProvides patient education regarding required study procedures/liliIf the Research Coordinator is a Registered Nurse, educates the patient and family regarding clinical condition, and/or disease process. If the Research Coordinator is not a RN, he/she will schedule educational time with a RN/liliIf the Research Coordinator is a Registered Nurse, identifies patients who require increased nursing assessment and management in addition to the clinical trial requirements and collaborate with other members of the healthcare team to ensure patient safety. If the Research Coordinator is not an RN, he/she will schedule educational time with a RN/liliCoordinates, schedules, and ensures timely completion of protocol-required events and other requirements (e.g., pharmacokinetics or dynamics, scans, study visits, QOL,)/liliAssesses individual patients for physical, psychosocial, and financial factors that could impact adherence with study requirements and implement interventions as necessary/liliEvaluates patients adherence to and documentation of self-administered protocol agents and the return of such agents/liliCollaborates with the investigator to determine disease response as defined by the protocol and communicates findings to the study team and other care providers/liliEvaluates patients adherence to and documentation of self-administered protocol agents and return of such agents/liliCollaborates with the investigator to determine if any treatment schedule or drug dose modification is necessary and communicates findings to the study team and other care providers/liliEnsures appropriate communication between research and clinical staff related to patient-specific care needs/liliEnsures evidence-based symptom management as permitted by the protocol/li/ulliDocumentation and Document Management/liulliDocuments all patient encounters in the legal medical record per licensure and institutional requirements/liliObtains documents from outside providers or laboratories that are needed as part of the research data/liliEducates other research team members and clinical staff regarding appropriate and accurate source documentation for patients of in clinical trials/liliAssesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents/liliMaintains the privacy and confidentiality of patients source documents/liliMaintains specified study documents in the Research Coordinator files/liliParticipates in the development of approved source documents, templates, or forms/li/ulliData Management and Information Technology/liulliAdheres to the data management plan per NEXT SOPs and sponsor data management plan/liliAssists in troubleshooting data entry issues/liliEnsures that relevant data from source documents are abstracted and entered into CRFs in a timely and accurate manner/liliEnsure that data recorded on the CRFs can be verified within the source documents/liliParticipates in quality control activities to ensure data integrity, including timely responses to database or sponsor queries/liliEnters data into electronic data capture for SAEs as appropriate/li/ulliRequired Education and Experience/liulliThe Research Coordinator must be knowledgeable of standard research and oncology care practices/liliTypically requires 5 or more years of experience/liliCurrent Texas or Virginia Registered Nursing License for RNs/liliBachelors degree required for non-RNs/liliOncology clinical trial experience preferred/liliResearch Coordination experience preferred/li/ul/ul/div