Clinical Studies Coordinator, Internal Medicine - Clinical
$57.5kFull-time
MD Anderson
Internal Medicine is looking for a Clinical Studies Coordinator. If you are passionate about clinical research, committed to quality and compliance, and motivated by the opportunity to make a difference in patients' lives, we invite you to join a team where your work has a direct impact on advancing science and improving outcomes for those we serve. Why Us? Join a collaborative and mission-driven research team dedicated to advancing innovative clinical discoveries that improve the lives of patients with cancer and complex medical conditions. In this role, you will have the opportunity to contribute directly to groundbreaking clinical trials, work alongside leading investigators and multidisciplinary experts, and play an integral part in bringing new therapies and treatment options to patients. Through the Division of Internal Medicine's Shared Service Model, you will gain exposure to a diverse portfolio of clinical research studies while developing expertise in study coordination, regulatory compliance, patient engagement, and data management. We foster a culture of teamwork, continuous learning, operational excellence, and professional growth, empowering employees to make meaningful contributions to research that transforms patient care. The ideal candidate is a highly organized, detail-oriented clinical research professional who thrives in a collaborative, fast-paced environment and is passionate about advancing patient-centered research. They possess strong communication, coordination, and problem-solving skills, demonstrate a commitment to regulatory compliance and quality, and can effectively balance multiple priorities while supporting investigators, research teams, and study participants. This is a hybrid position , with on-site presence required based on business needs, protocol requirements, and clinic schedules. The typical work schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. , with flexibility to accommodate study-related activities as needed. Minimum salary: $57,500 Midpoint salary: $72,000 Maximum salary: $86,500 Key Functions Clinical Research Coordination and Study Operations • Coordinate the day-to-day implementation and management of assigned clinical research protocols within the Division of Internal Medicine.
• Serve as a primary research coordinator for assigned studies, facilitating communication among investigators, sponsors, ancillary departments, and research staff.
• Coordinate protocol start-up activities including development of study tools, source documents, study calendars, and workflow processes.
• Assist with preparation and submission of protocol-related documentation to institutional departments and regulatory offices as required.
• Schedule and coordinate protocol-required procedures, laboratory testing, imaging, consultations, and study visits.
• Notify clinical and research laboratories of protocol-required laboratory collections including pharmacokinetic (PK), pharmacodynamic (PD), ECGs, specimen processing, and other protocol-specific procedures.
• Coordinate multidisciplinary communication to ensure protocol requirements are completed accurately and within required timelines.
• Maintain study documentation, regulatory binders, investigator files, and protocol records in accordance with institutional policies and Good Clinical Practice (GCP).
• Utilize institutional research systems (e.g., OnCore, Epic, Velos, or other applicable systems) to accurately document study activities and patient visits.
• Participate in sponsor monitoring visits, internal audits, and quality reviews by preparing study documentation and responding to requests. Patient Coordination and Clinical Research Support • Coordinate patient recruitment activities including screening, scheduling, and eligibility verification according to protocol requirements.
• Serve as a liaison between patients, investigators, physicians, nursing staff, sponsors, and ancillary departments throughout protocol participation.
• Coordinate informed consent activities in collaboration with the Principal Investigator and research team according to institutional policies.
• Ensure protocol-required procedures are completed according to study timelines and sponsor requirements.
• Monitor participant progress throughout study participation and communicate protocol-related issues to the research team.
• Collect, review, and submit protocol-required clinical data ensuring accuracy, completeness, and timeliness.
• Assist in resolving operational issues affecting study participants and research activities.
• Support studies involving chemotherapy, immunotherapy, targeted therapy, cellular therapy, and other investigational treatments as applicable. Regulatory Compliance and Quality Assurance • Ensure assigned studies are conducted in compliance with federal regulations, institutional policies, Good Clinical Practice (GCP), sponsor requirements, and protocol guidelines.
• Assist with preparation for sponsor monitoring visits, internal audits, FDA inspections, and other regulatory reviews.
• Maintain accurate and complete regulatory documentation for assigned studies.
• Monitor study activities to identify compliance concerns and communicate findings to research leadership.
• Assist in implementing corrective actions following monitoring visits or audit findings.
• Maintain current knowledge of institutional policies, regulatory requirements, and clinical research best practices. Data Entry and Research Documentation • Accurately enter and maintain clinical research data in institutional and sponsor-required electronic systems, including OnCore, electronic data capture (EDC) systems, Epic, and other applicable research databases.
• Ensure protocol-required patient visits, study milestones, participant status updates, and calendar activities are entered into OnCore within institutional timelines to support compliance, billing accuracy, and sponsor invoicing.
• Complete case report forms (CRFs) and electronic case report forms (eCRFs), ensuring data are accurate, complete, and submitted within sponsor-defined timelines.
• Review source documentation to verify accuracy, consistency, and completeness of data entered into clinical research systems.
• Resolve data queries generated by sponsors, monitors, or data management teams in a timely manner and collaborate with the research team to address discrepancies.
• Maintain accurate study documentation and research records in accordance with Good Clinical Practice (GCP), sponsor requirements, and institutional policies.
• Track protocol-required procedures, adverse events, deviations, and participant status to ensure research databases remain current.
• Perform routine quality checks of study data and documentation to identify and correct discrepancies before sponsor monitoring visits, internal audits, or regulatory inspections.
• Assist with maintaining essential study documents and ensuring research files are audit-ready throughout the lifecycle of the study.
• Collaborate with investigators, research nurses, data coordinators, and regulatory staff to ensure complete and accurate documentation supporting protocol compliance and research integrity. Shared Service Model and Team Collaboration • Support the Division of Internal Medicine Research Shared Service Model by providing clinical research support across multiple departments as operational needs require.
• Collaborate with research teams to promote standardized workflows, consistency in research processes, and operational efficiency.
• Share knowledge, tools, and best practices to improve coordination across the Division.
• Participate in departmental meetings, educational programs, and process improvement initiatives.
• Contribute to development and refinement of standardized research tools, templates, and workflow documents.
• Demonstrate flexibility in supporting cross-functional research activities while maintaining excellent customer service to investigators and research teams. EDUCATION
• Serve as a primary research coordinator for assigned studies, facilitating communication among investigators, sponsors, ancillary departments, and research staff.
• Coordinate protocol start-up activities including development of study tools, source documents, study calendars, and workflow processes.
• Assist with preparation and submission of protocol-related documentation to institutional departments and regulatory offices as required.
• Schedule and coordinate protocol-required procedures, laboratory testing, imaging, consultations, and study visits.
• Notify clinical and research laboratories of protocol-required laboratory collections including pharmacokinetic (PK), pharmacodynamic (PD), ECGs, specimen processing, and other protocol-specific procedures.
• Coordinate multidisciplinary communication to ensure protocol requirements are completed accurately and within required timelines.
• Maintain study documentation, regulatory binders, investigator files, and protocol records in accordance with institutional policies and Good Clinical Practice (GCP).
• Utilize institutional research systems (e.g., OnCore, Epic, Velos, or other applicable systems) to accurately document study activities and patient visits.
• Participate in sponsor monitoring visits, internal audits, and quality reviews by preparing study documentation and responding to requests. Patient Coordination and Clinical Research Support • Coordinate patient recruitment activities including screening, scheduling, and eligibility verification according to protocol requirements.
• Serve as a liaison between patients, investigators, physicians, nursing staff, sponsors, and ancillary departments throughout protocol participation.
• Coordinate informed consent activities in collaboration with the Principal Investigator and research team according to institutional policies.
• Ensure protocol-required procedures are completed according to study timelines and sponsor requirements.
• Monitor participant progress throughout study participation and communicate protocol-related issues to the research team.
• Collect, review, and submit protocol-required clinical data ensuring accuracy, completeness, and timeliness.
• Assist in resolving operational issues affecting study participants and research activities.
• Support studies involving chemotherapy, immunotherapy, targeted therapy, cellular therapy, and other investigational treatments as applicable. Regulatory Compliance and Quality Assurance • Ensure assigned studies are conducted in compliance with federal regulations, institutional policies, Good Clinical Practice (GCP), sponsor requirements, and protocol guidelines.
• Assist with preparation for sponsor monitoring visits, internal audits, FDA inspections, and other regulatory reviews.
• Maintain accurate and complete regulatory documentation for assigned studies.
• Monitor study activities to identify compliance concerns and communicate findings to research leadership.
• Assist in implementing corrective actions following monitoring visits or audit findings.
• Maintain current knowledge of institutional policies, regulatory requirements, and clinical research best practices. Data Entry and Research Documentation • Accurately enter and maintain clinical research data in institutional and sponsor-required electronic systems, including OnCore, electronic data capture (EDC) systems, Epic, and other applicable research databases.
• Ensure protocol-required patient visits, study milestones, participant status updates, and calendar activities are entered into OnCore within institutional timelines to support compliance, billing accuracy, and sponsor invoicing.
• Complete case report forms (CRFs) and electronic case report forms (eCRFs), ensuring data are accurate, complete, and submitted within sponsor-defined timelines.
• Review source documentation to verify accuracy, consistency, and completeness of data entered into clinical research systems.
• Resolve data queries generated by sponsors, monitors, or data management teams in a timely manner and collaborate with the research team to address discrepancies.
• Maintain accurate study documentation and research records in accordance with Good Clinical Practice (GCP), sponsor requirements, and institutional policies.
• Track protocol-required procedures, adverse events, deviations, and participant status to ensure research databases remain current.
• Perform routine quality checks of study data and documentation to identify and correct discrepancies before sponsor monitoring visits, internal audits, or regulatory inspections.
• Assist with maintaining essential study documents and ensuring research files are audit-ready throughout the lifecycle of the study.
• Collaborate with investigators, research nurses, data coordinators, and regulatory staff to ensure complete and accurate documentation supporting protocol compliance and research integrity. Shared Service Model and Team Collaboration • Support the Division of Internal Medicine Research Shared Service Model by providing clinical research support across multiple departments as operational needs require.
• Collaborate with research teams to promote standardized workflows, consistency in research processes, and operational efficiency.
• Share knowledge, tools, and best practices to improve coordination across the Division.
• Participate in departmental meetings, educational programs, and process improvement initiatives.
• Contribute to development and refinement of standardized research tools, templates, and workflow documents.
• Demonstrate flexibility in supporting cross-functional research activities while maintaining excellent customer service to investigators and research teams. EDUCATION
- Required: Bachelor's Degree
- Preferred: Master's Degree Public Health or related scientific field.
- Required: 3 years Research study or direct patient care experience obtained from nursing, data gathering or other related experience. or
- Required: 1 year Required experience with preferred degree.
- : May substitute required education degree with additional years of equivalent experience on a one to one basis.
- Requisition ID: 182479
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 57,500
- Midpoint Salary: US Dollar (USD) 72,000
- Maximum Salary : US Dollar (USD) 86,500
- FLSA: non-exempt and eligible for overtime pay
- Fund Type: Soft
- Work Location: Hybrid Onsite/Remote
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
Vacancy posted 3 days ago
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