Johns Hopkins University
Sr. Research Program Coordinator (Oncology)
Johns Hopkins University, Baltimore, Maryland, United States, 21276
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.
Specific Duties and Responsibilities
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.
Specific Duties and Responsibilities for GU Oncology Senior Research Program Coordinator
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 RedCap 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, CV's and IRB training documents for Good Clinical Practice.
Minimum Qualifications
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.
Salary Range Starting salary range: $41,300 - $72,300 annually (targeted $56,800).
Equal Opportunity Employer The Johns Hopkins University is committed to equal opportunity for its faculty, staff, and students. To that end, the university does not discriminate on the basis of sex, gender, marital status, pregnancy, race, color, ethnicity, national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status or other legally protected characteristic. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Equal Opportunity Employer.
EEO is the Law – https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf.
Accommodation Information If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.
Vaccine Requirements Johns Hopkins University requires all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. The following additional provisions may apply, depending on campus: pre-employment physical for positions in clinical areas requires documentation of immune status against Rubella, Measles, Mumps, Varicella, Hepatitis B, and Tdap. Vaccines for these diseases are given at no cost in our Occupational Health office.
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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.
Specific Duties and Responsibilities
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.
Specific Duties and Responsibilities for GU Oncology Senior Research Program Coordinator
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 RedCap 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, CV's and IRB training documents for Good Clinical Practice.
Minimum Qualifications
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.
Salary Range Starting salary range: $41,300 - $72,300 annually (targeted $56,800).
Equal Opportunity Employer The Johns Hopkins University is committed to equal opportunity for its faculty, staff, and students. To that end, the university does not discriminate on the basis of sex, gender, marital status, pregnancy, race, color, ethnicity, national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status or other legally protected characteristic. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Equal Opportunity Employer.
EEO is the Law – https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf.
Accommodation Information If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.
Vaccine Requirements Johns Hopkins University requires all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. The following additional provisions may apply, depending on campus: pre-employment physical for positions in clinical areas requires documentation of immune status against Rubella, Measles, Mumps, Varicella, Hepatitis B, and Tdap. Vaccines for these diseases are given at no cost in our Occupational Health office.
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