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Department:


13101_49710 Radiation Oncology-Biologi

Expected Weekly Hours:
 

4

Shift:
Position Purpose:


This position is responsible for coordinating all clinical research endeavors in the Department of Radiation Oncology. This includes responsibility for protocol preparation, IRB compliance, patient recruitment and enrollment, data collection, medical record documentation, quality assurance, maintenance of study drug records, report preparation and dissemination of protocol information to healthcare professionals and the public, training of healthcare professionals, educating of patients and family members, and active participation in program planning and development. The individual in this role interacts with the faculty as needed to complete these responsibilities as well as collaboratively with multiple physicians and Research RNs in both the Cancer Center and Hines VA Hospital.

Job Description Details:


This position is responsible for coordinating all clinical research endeavors in the Department of Radiation Oncology. This includes responsibility for protocol preparation, IRB compliance, patient recruitment and enrollment, data collection, medical record documentation, quality assurance, maintenance of study drug records, report preparation and dissemination of protocol information to healthcare professionals and the public, training of healthcare professionals, educating of patients and family members, and active participation in program planning and development. The individual in this role interacts with the faculty as needed to complete these responsibilities as well as collaboratively with multiple physicians and Research RNs in both the Cancer Center and Hines VA Hospital.

Protocol Administration:
Receives and reviews newly activated protocols, amendments,suspensions,and terminations; revises protocol consent forms to comply with federal,state and institutional review board (IRB) requirments; submits protocols, amendments,notices, suspensions, and terminations to the IRB for re-approval for continued participation; addresses all IRB concerns; responsible for reporting adverse drug reactions according to the guidelines of the NCI, FDA, sponsoring company and IRB; ensures that all materials are available for audit by study sponsor; assists auditors during review process;investigates auditors findings

and prepares written response for principal investivator; acts as a liaison for principal investigator to study sponsors; attends tumor board and start-up meetings.

Data Collection/Quality Control:
Abstracts and records physical findings, laboratory data, and other details essential to the study; coordinates the submission of pathology and radiotherapy materials pertinent to the study; submits data within the time frame specified in each protocol; responds in a timely manner to requests for clarification of the data submitted; oversee coordination of long term data collection; records and reports all adverse drug reactions according to NCI, FDA and IRB guidelines; ensures that oncology/medical staff are aware of study parameters including protocol dose modification schedules ensuring proper documentation; maintains and updates the department’s clinical research information database; generates ad hoc reports and manages queries.

Patient Identification/Eligibility:
Screening,recruitment,and enrollment of study participants; determines the eligibility as required by protocol by thoroughly reviewing patients' medical records; ensures that pre-study evaluations have been completed within specified time period as outlined in the protocol; informs investigator of the required studies/tests to be ordered to comply with study parameters; maintain contact with potential patients and on-study patients for adherence and support of clinical trial activities; interface with sponsors as

appropriate in determining eligibility; meet with patient and family, where appropriate to discuss protocol participation; answer patient and family questions and provide support.

Marketing and Promotion:
Maintains a comprehensive list of all protocols activated within the department, distributing to medical staff; facilitates deparmental research meetings updating PI's on status of clinical trial activity and opportunities; provides reporting of clinical trial activity including patient accruals to Director of Administration; serves as department representative at cancer clinical trials group data manager meetings.

Coordinate Grant Applications:
Assist with preparation and submission of all grant proposals including the budget breakdown and distribution of funds in the pre and post award sections of the Research Channel. Prepare and submit additional reports for all non-competitive and competitive renewal applications. Includes production of final application, completion of institutional information portions, sending complete application to agency, triage communication between supervisor and agency representatives; prepare necessary annual reports.

Position Requirements:


Education:
 Bachelors Degree in Nursing Required

Experience:
 3-5 years of previous job-related experience required, preferably prior experience working with IRB, basic understanding of research/clinical protocols and familiarly

with Hematology/Oncology/Radiotherapy practices.

Licensure/Certifications:


  • CPR (Cardiopulmonary Resuscitation)
  • Current Registered Nurse License State of Illinois
  • Research - CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is preferred.
Trinity Health's Commitment to Diversity and Inclusion

Trinity Health employs about 133,000 colleagues at dozens of hospitals and hundreds of health centers in 22 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.

Trinity Health's dedication to diversity includes a unified workforce (through training and education, recruitment, retention and development), commitment and accountability, communication, community partnerships, and supplier diversity.

Read the full job description and apply online on the recuiter's web-site

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