Research Coordinator

The 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.Research Coordinators attend study teleconferences with sponsors and clinical research organizations to assure continuity of information.Essential Duties and ResponsibilitiesEssential and other important responsibilities and duties may include but are not limited to the following:Protocol ComplianceIdentifies primary and secondary study objectives and outcome measuresAdheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical researchComplies with NEXT Oncology SOPsParticipates in providing timely, informative, and accurate communication with the interdisciplinary team to ensure protocol compliance and timelines of protocol-related proceduresCollaborates with the Principal Investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugsProvides protocol specific education to clinical staffFacilitates and participates in the preparation for an conduct of meetings/teleconferences with sponsors, monitors, and auditorsProvides timely, accurate, and complete reporting of serious adverse events, unanticipated problems, deviations, violations, and noncompliance to the IRB and sponsorContributes to the development of corrective and preventive action plans for unanticipated problems, deviations, violations, and issues of noncomplianceInformed ConsentIdentifies and intervenes to address barriers to effective informed consent discussionsand decision making (e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception)Describes and abides by institutional policy and processes for informed consentEnsures that the most current version of the IRB approved protocol consent document is used by the physician investigator when consenting or re-consenting a patientCollaborates with the physician investigator to ensure initial and ongoing consent process is performed and documentedAssesses ongoing consent through discussions with patients and reinforcement of educationAssesses patient's understanding of the information provided during the informed consent processEnsures timely re-consenting as needed by the physician investigatorDemonstrates understanding of tiered consent process when optional correlative studies (e.g., biospecimen, quality of life, patient-reported outcomes collections) are involvedConfirms informed consent is obtained prior to performing any study specific tasksManagement of Clinical Trial PatientsCollaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocolEducates the patient and family regarding protocol participationProvides patient education regarding required study proceduresIf 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 RNIf 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 RNCoordinates, schedules, and ensures timely completion of protocol-required events and other requirements (e.g., pharmacokinetics or –dynamics, scans, study visits, QOL,)Assess individual patients for physical, psychosocial, and financial factors that could impact adherence with study requirements and implement interventions as necessaryEvaluates patient's adherence to and documentation of self-administered protocol agents and the return of such agentsCollaborates with the investigator to determine disease response as defined by the protocol and communicates findings to the study team and other care providersEvaluates patient's adherence to and documentation of self-administered protocol agents and return of such agentsCollaborates 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 providersEnsures appropriate communication between research and clinical staff related to patient-specific care needsEnsures evidence-based symptom management as permitted by the protocolDocumentation and Document ManagementDocuments all patient encounters in the legal medical record per licensure and institutional requirementsObtains documents from outside providers or laboratories that are needed as part of the research dataEducates other research team members and clinical staff regarding appropriate and accurate source documentation for patients of in clinical trialsAssesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documentsMaintains the privacy and confidentiality of patients' source documentsMaintains specified study documents in the Research Coordinator filesParticipates in the development of approved source documents, templates, or formsData Management and Information TechnologyAdheres to the data management plan per NEXT SOPs and sponsor data management planAssists in troubleshooting data entry issuesEnsures that relevant data from source documents are abstracted and entered into CRFs in a timely and accurate mannerEnsure that data recorded on the CRFs can be verified within the source documentsParticipates in quality control activities to ensure data integrity, including timely responses to database or sponsor queriesEnters data into electronic data capture for SAEs as appropriateRequired Education and ExperienceThe Research Coordinator must be knowledgeable of standard research and oncology care practicesTypically requires 5 or more years of experienceCurrent Texas Registered Nursing License for RNsBachelor's degree required for non-RNsOncology clinical trial experience preferredResearch Coordination experience preferredWhy Join Us?At NEXT Oncology (an Avacare Business), you'll be part of a mission-driven team that values collaboration, precision, and patient safety. Our team is known for its supportive culture, strong communication, and commitment to excellence in clinical research.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoeThe potential base pay range for this role, when annualized, is $43,400.00 - $108,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.J-18808-Ljbffr