Research Data Coordinator
Research Data Coordinator
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Job Description
Overview
Hello humankindness Located conveniently in the heart of Phoenix ArizonaSt. Josephs Hospital and Medical Center is a 571-bed not-for-profit hospital that provides a wide range of health social and support services. Founded in 1895 by the Sisters of Mercy St. Josephs was the first hospital in the Phoenix area. More than 125 years later St. Josephs remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care medical education and research. St. Josephs includes the internationally renowned Barrow Neurological Institute Norton Thoracic Institute Cancer Center at St. Josephs Ivy Brain Tumor Center and St. Josephs Level I Trauma Center (which is verified by the American College of Surgeons).
The hospital is also a respected center for high-risk obstetrics neuro-rehabilitation orthopedics and other medical services. St. Josephs is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day approximately 20 percent of the hospitals patients have traveled from outside of Arizona and the United States to seek treatment at St. Josephs. U.S News & World Report routinely ranks St. Josephs among the top hospitals in the United States for neurology and addition St. Josephs boasts the Creighton University School of Medicine at St. Josephs and a strategic alliance with Phoenix Childrens Hospital. St. Josephs is consistently named an outstanding place to work and one of Arizonas healthiest employers.
Come grow your career with one of Arizonas Most Admired Companies.
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Responsibilities
The Ivy Brain Tumor Center is a non-conventional non-profit program offering state-of-the-art clinical trials for patients with the most aggressive form of brain cancer. It is home to the largest collection of Phase 0 trials for brain tumors in the world. Our multidisciplinary team of brain tumor specialists and scientists are accelerating drug discovery and precision medicine in neuro-oncology to identify the most promising first-in-class therapies for brain tumor patients. Our day-to-day interactions with patients caregivers and each other are grounded in transparency: our conversations are always two-way and our labs are open to ensure efficient collaboration. Everyone at the Ivy Brain Tumor Center is passionate about identifying and accelerating treatments that will make a meaningful difference in patients lives. Here innovation never stops because for us this work is personal.
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The Research Data Coordinator (RDC) is a highly skilled role that autonomously reviews and synthesizes information from medical records (clinic notes pathology reports radiology reports patient questionnaires etc.) and source documents to extract industry cooperative and investigator-initiated trial data as specified by assigned research protocols. The position is responsible for protocol-specific data requirements for multiple complex research projects while ensuring data requirements are in alignment with good clinical practice according to Federal regulations.
Principal Duties and Responsibilities:
- Maintains a high-level of expertise and abstracts information independently from a wide range of data collection tools or the subjects medical record and enters required protocol data into the study-designated data collection system
- Ensures data is entered/reported in a timely manner keeping with clinical trial agreements and institutional standard operating procedures.
- Identifies data discrepancies and/or missing data and follows up with investigators and the study team to resolve.
- Reports data quality issues at study meetings and provides suggestions for ways to resolve the issue
- Reviews monitoring/audit reports database queries and resolve errors to ensure the integrity of data.
- Provides coverage for the team as appropriate.
- Responsible for reporting on each study including information related to protocol activity data monitoring/auditing and other research information; presents this information at regular research staff meetings.
- Ensure data compliance for ICH GCP and regulatory authorities.
- Develops methods for tracking and reporting data and monitors incoming and outgoing data to ensure data integrity and compliance with applicable regulatory agency standards.
- May support the lead data management specialist in the development of the study database according to clinical trial specifications including: eCRF design user requirements edit check specifications user acceptance testing (UAT) medical coding query management data validation programming and testing data imports/exports.
- Ensure data system compliance for ICH GCP and regulatory authorities.
- May train others in work responsibilities.
- Collaborates with the investigator(s) study coordinator research nurse monitors and data manager regarding the protocol requirements.
- Collaborates with the study coordinator research nurse or research assistant to document and report study patient enrollment treatment and follow-up into the study database including protocol adherence adverse events and treatment outcomes.
- Assists with the coordination of organized meetings conference calls and training.
- Participates in site initiation interim monitoring and close-out visits internal audits and external audits/inspections.
- Attends and actively participates in regularly scheduled multidisciplinary tumor boards staff meetings disease site program research meetings and role-specific meetings.
- Participates in department-based process improvement or advisory groups.
Qualifications
Required Qualifications: A minimum of a HS diploma and 1 year of clinical research/ experience; or equivalent combination of education training and experience.
Preferred Qualifications/Skills:
Strong medical terminology understanding Certification in Clinical Research preferred (e.g. CCRC CCRP) Strong knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Proven ability to work with others to deliver results to the appropriate quality and timeline metrics Must possess effective verbal and written communication skills as well as excellent interpersonal skills with staff and other healthcare professionals Must have the ability to prioritize and pace oneself when working under the pressure of deadlines and work volume Previous experience taking place in the oncology research setting preferred Thorough knowledge of EMR systems (e.g. Cerner) clinical trial management systems (e.g RealTime) or other data entry systems (e.g. RedCap Medidata Rave)
High School Graduate or GED upon hire and1 year of clinical research/experience; or equivalent combination of educationtraining and experience required.
Previous experience taking place in the oncology research setting preferred
Bachelors degree preferred
Preferred Licensure and Certifications:
Clinical Research Associate (CCRA)
Certified Clinical Research Coordinator ACRP (CCRC-ACRP)
Certified Clinical Resarch Professional SOCRA (CCRP-SOCRA)
Additional Requirements (e.g. two letters of recommendation)
Required Experience:
IC
Employment Type
Unclear
