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Job Req ID:  15422

Research Program Coordinator

The Department of Oncology is seeking a Research Program Coordinator to work under the direct supervision of the Sr. Clinical Research Program Manager and Principal Investigator(s).  The Research Program Coordinator is responsible for data management, regulatory activities, and research activities of patients entered onto research protocols at the Sidney Kimmel Comprehensive Cancer Center and possibly, external institutions. The Research Program Coordinator is responsible for the organization, submission, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner.  This is an introductory level position in managing clinical trials and/or registry databases within the Developmental Therapeutics Program.  Responsibilities will also include ongoing IRB submissions of supported protocols, assist the research nurses in monitoring protocol compliance, and assist the Program Manager with affiliate oversight.

Specific Duties and Responsibilities:

  1. Coordinate patient enrollment, data abstraction, case report form completion and submission, query resolution and responses, specimen shipping, and other protocol-related tasks. Adhere to all protocol requirements to ensure the validity of clinical research patient data.  May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
  2. Compile and maintain research charts for trial patients. Maintain patient registrations and relevant data points in databases.
  3. In conjunction with clinical personnel, write and prepare serious adverse event reports and submit according to sponsor and IRB requirements. 
  4. Complete protocol activities for patients in follow-up, including ensuring appointments for follow-up visits, contacting patients to collect survival data and disease status, and administering quality of life questionnaires. 
  5. Maintain detailed working knowledge of all assigned protocols and be a resource for the principal investigators and nurses regarding protocol questions and sponsor requirements.
  6. Communicate regularly with principal investigators, research nurses and the Program Manager to review data accuracy and overall study progress. 
  7. Maintain electronic regulatory binder for each assigned protocol.
  8. Prepare continuing reviews, protocol events, safety reports, and protocol amendments for submission to the JHM IRB through the eIRB electronic system.  Prepare reports on individual patients or the study as required by the principal investigators and/or external agencies. 
  9. Distribute protocol information and updates to the study team.
  10. Submit, verify, and maintain protocol-specific information on the Cancer Center’s Protocol Library and/or CRMS patient tracking system.
  11. Attain a high level of expertise in institutional databases including EPIC, CRMS, and eIRB.
  12. Prepare for and participate in monitoring and audits of studies. 
  13. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Demonstrate proficiency in research documentation standards.
  14. Participate in all mandatory meetings to develop increasing knowledge of clinical trials.  Complete minimum requirements for continuing education units. 



BA/BS degree with course work in sciences and some relevant experience required.  Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.



JHU Equivalency Formula:  30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience.  Additional related experience may substitute for required education on the same basis.  For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.



Classified Title:  Research Program Coordinator
Role/Level/Range: ACRO/03/CD
Salary:  $16.09 - $22.12
Status:  Full-Time
Department name: 10002926-Cancer Chemical & Structural Biology 

Work Schedule/Hours: Monday-Friday, 8:30a-5p 
Location: 04-MD:School of Medicine Campus 
Personnel area: School of Medicine




The successful candidate(s) for this position will be subject to a pre-employment background check.


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