Role Description
Texas Oncology is looking for a Clinical Research Coordinator - Trial Prescreening to join our team! This remote position supports Texas Oncology's Clinical Research program across our statewide network. Candidates must reside in the state of Texas. Typical hours for this position are Monday through Friday, 8:30 a.m. to 5:00 p.m. This position can be a level 1, 2 or Sr based on candidate experience.
What does the Clinical Research Coordinator - Trial Prescreening do? (including but not limited to)
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Responsible for supporting the management and coordination of tasks for multiple clinical research studies.
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Screening patients for eligibility and participating in the subjectβs study visits and required activities per protocol.
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Assuring protocol compliance for all patients enrolled in the trial.
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Participation in the informed consent process.
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Perform ongoing assessments and documentation in collaboration with physicians and other providers.
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Participation in required training and education.
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Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPAA.
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Supports and adheres to US Oncology Compliance Program, including the Code of Ethics Business Standards.
Responsibilities
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Reviews physician referrals, patient records, and other available data sources to identify potential candidates for clinical trials based on protocol-specific eligibility criteria.
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Conducts prospective prescreening activities, including review of patient lists, schedules, disease registries, pathology reports, biomarker reports, and electronic medical records to identify potential research participants.
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Performs trial matching by comparing patient clinical characteristics, diagnosis, treatment history, staging, biomarker status, and other relevant information against available clinical trial inclusion and exclusion criteria.
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Collaborates with physicians, research nurses, Clinical Research Coordinators, and other research staff to communicate potential trial opportunities and facilitate patient referrals to study teams for further evaluation.
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Maintains accurate documentation of prescreening activities, referral outcomes, trial matching results, and patient tracking information in applicable systems and databases.
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Supports the development and maintenance of prescreening workflows, patient identification processes, trial recruitment strategies, and study-specific screening tools designed to improve clinical trial enrollment.
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Maintains current knowledge of the clinical trial portfolio, protocol eligibility requirements, disease-specific treatment pathways, and emerging research opportunities to effectively identify potential participants.
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Participates in required training, education programs, quality assurance activities, audits, and process improvement initiatives.
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Assists with maintaining study-related documentation, recruitment materials, and trial availability resources in accordance with organizational policies, SOPs, and applicable regulations.
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Performs other duties as assigned to support clinical trial recruitment, prescreening, and enrollment objectives.
Qualifications
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Level 1: Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
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Minimum one year of experience in a clinical or scientific related discipline, preferably in oncology required.
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Level 2: Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.
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SoCRA or ACRP certification preferred.
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Level Sr: Minimum seven years of experience in a clinical or scientific related discipline required.
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Minimum five years of oncology and/or research experience preferred.
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SoCRA or ACRP strongly preferred.
Physical Demands
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Requires standing and walking for extensive periods of time.
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Occasionally lifts and carries items weighing up to 40 lbs.
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Requires corrected vision and hearing to normal range.
Work Environment
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Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations, and other conditions common to an oncology/hematology clinic environment.