Clinical Research Coordinator Job Code: MES DM

US Oncology
Webster, TX
Sep 07, 2017
Oct 07, 2017
Contract Type
Full Time
Texas Oncology in Webster, TX is searching for a Clinical Research Coordinator for their Deke-Slayton location. This is a Monday-Friday 8:30a-5p position with no weekends, call or major holidays. Under general supervision of a physician and clinic nurse (if applicable), the Clinical Research Coordinator is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials. Collaborates with physician in determining eligibility of patients for clinical trials. Provides education to staff and patients. Ensures 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. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

Texas Oncology delivers high-quality, high-touch care to help cancer patients achieve "More breakthroughs. More victories."® in their fight against cancer. We are an independent, physician-led practice delivering leading-edge technology and treatment options and conducting innovative research. Founders of the practice pioneered community-based care to enable more cancer patients to receive high-quality care while staying close to the critical support of family and friends.

Texas Oncology has more than 150 sites of service throughout Texas, with more than 350 physicians dedicated to serving our patients. On average, we treat more than 50,000 new cancer patients each year, with documented growth year over year. Texas Oncology pioneered the concept of community-based, outpatient, multidisciplinary cancer centers. We give local communities access to leading-edge technology that was previously only available in larger metropolitan areas. Texas Breast Specialists and Texas Urology Specialists are a part of Texas Oncology. Texas Oncology is an affiliate of The U.S. Oncology Network, which is owned by McKesson Specialty Health, a division of McKesson Corporation.

-Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
-Oversee subject enrollment to ensure that informed consent is properly obtained and documented (under the supervision of the PI
-Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability documents.
-In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
-May be responsible for financial tracking and NSOC (Non-standard of Care) invoicing.
-Responsible for accurate documentation and reporting, participates in auditing activities
-Maintains regulatory documents in accordance with USOR-SOP’s and applicable regulations.
-Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
-May collaborate with research site leader in the study selection process.
-Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors.
-Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
-May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.
-May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.
-Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
-Order patients scans per protocol
-Required to attend all new study site initiation visits to learn about upcoming studies, E-learning modules, and Investigator meetings
-Enter patients regimens, do chemo teaching, and arrange schedules with physicians
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices- Maintain required records of study activity including case report forms, drug dispensation records, and/or regulatory forms
- Communicate with laboratories or investigators regarding laboratory findings
- Order study drugs (IP) and supplies as necessary for study completion
- Participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies and issues
-Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups, including USOR-QA team.-Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
-Track enrollment status of subjects and document dropout information such as dropout causes and subject contract efforts.
-Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
-Record adverse events and inform the investigators regarding the timeline for reporting of events to oversight agencies.
-CRCII may be responsible for helping to prepare study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports, study protocols including guidelines for administration or data collection procedures.
-Communicate with subjects to obtain follow-up information regarding ongoing event.
-Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.

-Bachelor's degree preferred. Associate’s degree in clinical or scientific related discipline desired
-Minimum three years’ experience in a clinical or scientific related discipline
-Oncology experience strongly preferred
-Registered Nurse (RN) certification and experience strongly preferred
-SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) certification preferred, or to be obtained within 1 year of employment
-Knowledge of computer applications regarding Rdc & eSAE reporting

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.

The vision of Texas Oncology is to be the premier provider of oncology and hematology care in the Southwest. We have high standards for patient satisfaction and offer exceptional value in cancer care. We also strive to advance clinical research and develop innovative approaches to treatment of oncology and hematology disorders.

The mission of Texas Oncology is to provide "More breakthroughs. More victories." To this end, we give patients access to the highest quality cancer care available today within their own local communities. Our cutting-edge technologies, treatments and research are offered in welcoming and comfortable environments. We maintain comprehensive quality oversight and responsible financial management. At all times, we pride ourselves in being moral, ethical and efficient as a medical practice and employer.

We extend an extremely competitive offering of benefits to employees, including Medical Health Care, Dental Care, Vision Plan, 401-k with a matching component, Life Insurance, Short-term and Long-term disability and Wellness & Perks Programs.

Come join our growing organization and enjoy knowing that you work for an organization dedicated to making the lives of others better.

The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Category: Clinical
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