Clinical Research Coordinator
Under general direction of the Manager, this position is responsible for implementing and coordinating oncology research projects) conducted through the Oncology Research Department of MedStar Health Research Institute. The Clinical Research Coordinator is accountable to ensure that research is conducted in compliance with all federal, state, local and other regulatory bodies, while effectively coordinating a portfolio of trials, and facilitating participant accrual to appropriate trials. Principal Duties and Responsibilities: 1) Serve as a resource for oncology research protocols and related issues. Confer with sponsors, investigators, and staff regarding study issues. 2) Maintain detailed knowledge of all components of oncology trial requirements and research procedures, ensuring protocol adherence. Communicate specialized knowledge of research studies, research methodologies and practices to all appropriate persons. 3) Maintain awareness, and possess working knowledge, of applicable federal, state, local, and other regulations and guidelines pertaining to departmental research. Implement and apply these regulations in the conduct of research work to ensure the highest quality research activities from site selection through study closure. 4) Identify and screen potential study participants. Discuss protocol participation with potential participants and others as indicated. Verify participant eligibility according to protocol specific criteria. 5) Coordinate and finalize the informed consent process for study participants according the departmental, institutional, state and federal regulations and guidelines. Document informed consent process. 6) Effectively facilitate participant accrual to appropriate trials, while ensuring adherence to human subject protection and other research guidelines. Collaborate with Investigator, and sponsor as applicable, to determine appropriate eligibility maintaining all required documentation for eligibility verification. 7) Manage multiple trials and work with appropriate support staff/departments to ensure study requirements are met. Ensure completion of all tests/procedures/assessments within indicated protocol/project timeframes. Provide clear and appropriate documentation for all study related activities. 8) Design tools and maintain materials that aid in the accurate data collection, reporting and conduct of the study and in compliance with Good Clinical Practice. Recommend changes/additions to established data forms where appropriate. Utilize resources to enhance efficient patient accrual, protocol implementation, protocol maintenance, working together with investigators and other research colleagues throughout the protocol life cycle. 9) Monitor the course of study participants, reporting all required side effects, deviations, disease status, and other data related to protocol adherence in an accurate manner within protocol, sponsor and IRB timeframes. Complete and maintain required records of study activity including, but not limited to: case report forms, research files, adverse event reporting, database records, and thorough source documentation substantiating all reported data. 10) Demonstrate good judgment to make decisions, adjust priorities, and manage schedule to ensure that accurate work is accomplished within the required timepoints. Utilize critical thinking to collect, analyze and evaluate all relevant information prior to taking action. 11) Adhere to protocol specific and local requirements while accurately and completely coding and submitting data and materials in a timely manner. Ensure data quality and integrity in research databases for each stage of data collection. Assist in collection, preparation, and analysis of information for institutional special reviews and/or studies; Collaborate with investigators and research team in development of special projects or initiatives. 12) Prepare regular reports of research activity including, but not limited to: assisting in preparation of data safety monitoring reports, protocol-specific patient reports/chart review, and pre-inspection reports. Consistently ensure regulatory readiness for external inspection and sponsor monitoring visits. Respond to follow-up requests as needed. 13) Attend conferences, training programs, departmental research meetings, sponsor-initiated meetings, workshops, seminars, webinars as assigned, to keep abreast with project objectives, acquire new and/or updated knowledge in area of expertise relevant to current position. Prepare for, and facilitate meetings as appropriate. Share information gained with pertinent staff. 14) Function as a liaison between the Washington Cancer Institute (WCI) research program and those within the MedStar Georgetown Oncology Network in relation to clinical research and protocol-specific conduct. Facilitate discussions, and meetings as required with Network Investigators, research staff and WCI protocol research team. Participate in protocol-specific start-up and progress meetings in support of Network objectives as needed. 15) Integrally involved in facilitating research billing processes including, but not limited to: being the 'gate-keeper' in steering all research-related services to the appropriate billing category -Help in the patient-care costs (both billable and non-billable) process to ensure that research non-billable services (where research is guarantor) are not billed to study participants or insurers. 16) Work together with the Business/Administrative division of the department in facilitating the Medicare Coverage Analysis process. Ensure Medicare clinical trial billing forms are submitted to providers as applicable. Assist in billing reconciliation process as needed. Abide by MHRI policies regarding Medicare billing, attending any billing training modules as directed. Participate in and promote the prevention, detection, and resolution of instances of noncompliance with departmental and institutional billing policies and procedures. 17) Consistently demonstrate support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner; 18) Perform other duties as assigned. Minimum Qualifications: Education: Bachelors degree in health science or related degree and/or equivalent work experiences such that the objectives of the position are equaled. Experience: At least twelve months of clinical research work in the areas of recruitment, enrollment, monitoring, and reporting data on clinical trial participants is highly preferred. Two or more years of oncology experience strongly preferred. Knowledge of oncology-specific terminology is preferred. Duties require close proximity to location where administration of chemotherapy is performed.