Clinical Research Coordinator I- Plano West
US Oncology Network-wide Career Opportunities, Plano, TX, United States
Overview
Texas Oncology is looking for a Clinical Research Coordinator to join our team! This position will support the Plano West location in the Oncology Clinical Research department. Typical hours are Mon‑Fri 8:30am‑5:00pm. This position can be a level 1, 2, or Sr based on candidate experience.
Benefits
We offer our employees a competitive benefits package that includes Medical, Dental, Vision, Life Insurance, Short‑term and Long‑term disability coverage, a generous PTO program, a 401k plan with company match, a Wellness program, Tuition Reimbursement, Employee Assistance program and discounts.
What does the Clinical Research Coordinator do? (including but not limited to)
Responsible for supporting the management and coordination of tasks for multiple clinical research studies, including screening patients for eligibility and participating in the subject’s study visits and required activities per protocol. Duties include assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, performing ongoing assessments and documentation in collaboration with physicians and other providers, and participation in required training and education. Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures, principles of Good Clinical Practice, and applicable federal, state, and local regulations.
Supports and adheres to US Oncology Compliance Program, including the Code of Ethics Business Standards.
Responsibilities
Screens potential patients for protocol eligibility, presents trial concepts and details, participates in the informed consent process, and enrolls patients on clinical trials.
Assists with patient care in compliance with protocol requirements, may disburse investigational drug and maintain investigational drug accountability, participates in data collection, entry, and reporting for the subjects.
In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study drug, and thoroughly documents all findings.
Participates in required training and education programs, monitoring and auditing activities; may work directly with sponsors and participate in scheduling monitoring and auditing visits while onsite.
Assists with collection and maintenance of regulatory documents in accordance with USOR SOPs and applicable regulations.
May assist in packing and shipping of lab specimens to central vendors; may be required to complete Hazmat and/or IATA training.
Qualifications
Level 1
Associate’s degree in a clinical or scientific related discipline required; Bachelor's degree preferred.
Minimum one year of experience in a clinical or scientific related discipline, preferably in oncology.
Level 2
(in addition to level 1 requirements)
Minimum five years of experience in a clinical or scientific related discipline, preferably in oncology.
SoCRA or ACRP certification preferred.
Level Sr
(in addition to level 1 and 2 requirements)
Minimum seven years of experience in a clinical or scientific related discipline.
Minimum five years of oncology and/or research experience preferred.
SoCRA or ACRP strongly preferred.
Physical Demands
Requires standing and walking for extensive periods of time, occasional lifting and carrying items up to 40 lbs, requires corrected vision and hearing to normal range. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Work Environment
Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
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Texas Oncology is looking for a Clinical Research Coordinator to join our team! This position will support the Plano West location in the Oncology Clinical Research department. Typical hours are Mon‑Fri 8:30am‑5:00pm. This position can be a level 1, 2, or Sr based on candidate experience.
Benefits
We offer our employees a competitive benefits package that includes Medical, Dental, Vision, Life Insurance, Short‑term and Long‑term disability coverage, a generous PTO program, a 401k plan with company match, a Wellness program, Tuition Reimbursement, Employee Assistance program and discounts.
What does the Clinical Research Coordinator do? (including but not limited to)
Responsible for supporting the management and coordination of tasks for multiple clinical research studies, including screening patients for eligibility and participating in the subject’s study visits and required activities per protocol. Duties include assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, performing ongoing assessments and documentation in collaboration with physicians and other providers, and participation in required training and education. Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures, principles of Good Clinical Practice, and applicable federal, state, and local regulations.
Supports and adheres to US Oncology Compliance Program, including the Code of Ethics Business Standards.
Responsibilities
Screens potential patients for protocol eligibility, presents trial concepts and details, participates in the informed consent process, and enrolls patients on clinical trials.
Assists with patient care in compliance with protocol requirements, may disburse investigational drug and maintain investigational drug accountability, participates in data collection, entry, and reporting for the subjects.
In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study drug, and thoroughly documents all findings.
Participates in required training and education programs, monitoring and auditing activities; may work directly with sponsors and participate in scheduling monitoring and auditing visits while onsite.
Assists with collection and maintenance of regulatory documents in accordance with USOR SOPs and applicable regulations.
May assist in packing and shipping of lab specimens to central vendors; may be required to complete Hazmat and/or IATA training.
Qualifications
Level 1
Associate’s degree in a clinical or scientific related discipline required; Bachelor's degree preferred.
Minimum one year of experience in a clinical or scientific related discipline, preferably in oncology.
Level 2
(in addition to level 1 requirements)
Minimum five years of experience in a clinical or scientific related discipline, preferably in oncology.
SoCRA or ACRP certification preferred.
Level Sr
(in addition to level 1 and 2 requirements)
Minimum seven years of experience in a clinical or scientific related discipline.
Minimum five years of oncology and/or research experience preferred.
SoCRA or ACRP strongly preferred.
Physical Demands
Requires standing and walking for extensive periods of time, occasional lifting and carrying items up to 40 lbs, requires corrected vision and hearing to normal range. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Work Environment
Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
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