Sr. Research Program Coordinator

We are seeking a Sr. Research Program Coordinator. Under the direct supervision of the Sibley Research Program Manager and the Principal Investigators, the Sr. Research Program Coordinator is 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 will assist with orientation of less senior research staff in protocol and clinical research information. The Sr. Research Program Coordinator may also have limited patient exposure and clinical responsibilities for assigned research protocols. This is an intermediate level position in managing clinical trials and/or registry databases within the Research Program at Sibley Memorial Hospital.

Specific Duties & 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.
• Facilitate the full cycle of the protocol approval process – development, submission, contract negotiation, budget development, interaction with Cancer Center Cores.
• Maintains regulatory binder for each assigned protocol. Prepares and submits annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data.
• 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.
• Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems.
• Maintains a research chart for each patient. Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication.
• Verifies scheduling of patient appointments, tests, and follow up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements. May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
• Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.
• Will develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis.
• Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. May participate in the development of invoicing schedules.
• Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Enters patient demographic and clinical data into institutional database as required. Responds in a timely manner to special projects or queries related to the data.
• May assist clinicians/clinical research coordinators with patient screening, recruitment, and consenting. May perform interviews, complete structured tests, and collect pertinent data with potential/active research participants in the clinic.
• Prepares for and participates in monitoring and audits of studies. Corrects errors in database 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.

Minimum Qualifications

• Bachelor's Degree in related discipline.
• Three years related experience.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Classified Title: Sr. Research Program Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $40,100 - $55.140 - $70,180 (Commensurate with Experience)
Employee group: Full Time
Schedule: M-F 8:30am- 5:00pm
Exempt Status: Exempt
Location: Hybrid/District of Columbia
Department name: SOM Onc Clinical Trials
Personnel area: School of Medicine

Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:

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.

**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

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

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer

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.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.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 accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and 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. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

Note: Job Postings are updated daily and remain online until filled.

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

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 HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm