Sr. Research Program Coordinator; Oncology

Overview

Under the direct supervision of the GU Clinical Research Program Manager or the Principal Investigator, we are seeking a Sr. Research Program Coordinator who will be responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols at the Sidney Kimmel Comprehensive Cancer Center and participating sites. The Sr. Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials and may assist with orientation of less senior research staff in protocol and clinical research information.

This is an intermediate level position in managing clinical trials and/or registry databases within the GU Oncology Program.

• Maintains good working knowledge of all assigned protocols and reporting requirements. Works on complex clinical studies which require a high level of knowledge, coordination, and data abstraction. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library.
• Maintains regulatory binder for each assigned protocol. Prepares and submits annual renewal requests, amendments, according to IRB and Sponsor requirements.
• May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. Will design and create protocol specific case report forms as needed. May also assist less experienced staff in design and creation of such forms.
• Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review regulatory accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.
• Prepares for and participates in monitoring and audits of studies. Corrects errors when necessary. Writes responses to audit reports with input from the Principal Investigator.
• Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies. May instruct introductory level clinical research personnel in these guidelines and policies.
• Assists with study budget and invoice preparation as needed.

• Ensures smooth implementation of new trials from IRB approval through study activation including collection of regulatory documentation for Sponsor and Investigator initiated studies.
• Working closely with Sponsors and Investigators, will submit and track each assigned protocol amendment through the IRB/subcommittee approval process, revise Red Cap database as applicable and update all manuals and documents pertaining to the amendment.
• Assist in ongoing reviews of all regulatory binders to ensure that documents are up to date and meet all Sponsor, protocol and Cancer Center requirements. Will work with lead study coordinators, research nurses and investigators to address issues identified in the review of regulatory binders.
• Maintain central regulatory files for all staff including licenses, master delegation logs, CVs and IRB training documents for Good Clinical Practice.

• Bachelor's Degree in related discipline.
• Three years related experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.

Classified

Title:

Sr. Research Project Coordinator

Job Posting Title (Working Title):
Sr. Research Program Coordinator (Oncology)

Role/Level/Range: ACRP/03/MB

Starting Salary Range: $41,300 - $72,300 Annually ($56,800 targeted; Commensurate w/exp.)

Employee group:
Full Time

Schedule:

Mon - Fri / 8:30a - 5p

FLSA Status:
Exempt

Location:

School of Medicine - East Baltimore Campus

Department name:

-SOM Onc Urologic Oncology

Personnel area:
School of Medicine

Total Rewards

The referenced base salary range represents the low and high end of Johns Hopkins University s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate s geographic location, skills, work experience, market conditions, education/training and other qualifications.

Johns Hopkins offers a total rewards package that supports our employees  health, life, career and retirement. More information can be found here: (Use the "Apply for this Job" box below)..

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these…