We are seeking a **_Research Program Coordinator_** to work under the Clinical Research Program Manager in the SKCCC Coordinating Center. Will be responsible for dispersing, collecting, and monitoring research information on multi-site investigator-initiated studies being managed by the Sidney Kimmel Comprehensive Cancer Center (SKCCC) Coordinating Center. Maintain compliance of the assigned research studies, including coordinating study activation related documents and submissions to pertinent regulatory agencies, assisting database design, approval, and implementation, amendment management, subject eligibility review, and monitoring regulatory and subject compliance for external sites. This is the entry-level position with the SKCCC Coordinating Center. Candidate will report to the Coordinating Center Clinical Research Program Manager and work closely with the Principal Investigators. **Specific Duties & Responsibilities** + Maintain good working knowledge of all assigned protocols and reporting requirements for regulatory and subject data compliance. + Review study documents, prepare for JHM IRB submissions and other regulatory agencies such as NCI, FDA, and ClinicalTrials.gov. + Organize regularly study progress meetings among Johns Hopkins study team and all participating sites. + Works closely with PI, study biostatistician, Coordinating Center Clinical Research Manager, and other Clinical Research Office (CRO) members to develop electronic case report forms (i.e., REDCap) and study calendars. + Work closely with Johns Hopkins study team to ensure subject eligibility, data, and safety compliance of local subjects. + Comply with CRO Quality Assurance staff on requests and resolution for internal monitoring and other data safety reviews. + Assist PI and study biostatistician on database lock, readiness for data analysis, and reporting out to regulatory agencies such as NCI, FDA, and ClinicalTrials.gov. + _Ensure external sites are following compliance standards._ + Distribute all protocol information (e.g., protocols, consent, study manuals, amendments) to external sites, maintain an accurate distribution and approval log and regulatory binder. + Work closely with the Coordinating Center Research manager and Johns Hopkins PI to organize the site initiation visits for external sites, complete site-readiness and activation review. + Assists the PI in the orientation of external site staff in trial management procedures, including the use of study databases and case report forms. + Work with external sites for central registration of all study participants in multi-site trials. + Ensure that external research staff maintain complete and accurate research data and charts on a real time basis and are well prepared for auditing and monitoring visits. + Coordinate with external research staff on database lock, study close-out activities, and termination. + Ensure SKCCC Standard Operating Procedures are in practice + Ensure that coordinating center standards for performance of clinical trials at multiple sites are adhered to. + Ensure system for generation, tracking, and resolution of data queries is adhered to. + Coordinate and conduct audits, monitoring visits and inspections at all participating sites. Prepare reports for audit and monitoring results. Notify appropriate authorities of major violations. + Comply with ICH Good Clinical Practice, IRB, and NCI Coordinating Center policies and procedures. Will instruct and train research personnel assigned to multi-center trials in these guidelines and practices. **Special Knowledge, Skills & Abilities** + Proficiency in the use of software applications, databases, spreadsheets, and word processing. + Knowledge of research methodology and clinical research practices and principles. + Ability to handle multiple and competing priorities. + Ability to work independently and autonomously. + Excellent organizational skills. + Excellent attention to detail. + Excellent time management skills. + Highly developed interpersonal skills and ability to interact appropriately and productively with staff at all levels is highly desired. + Knowledge of medical terminology. + Familiar with medical and laboratory procedures is highly desirable. + Highly effective verbal and written communication skills. + Must be proficient in Microsoft Office, especially Excel and Word, and a working knowledge of Access or other relational databases. **Minimum Qualifications** + Bachelor's degree in related discipline. + Additional experience may substitute for education, to the extent permitted by the JHU equivalency formula. **Preferred Qualifications** + Certification as a Clinical Research Professional. Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $17.20 - $30.30 HRLY ($23.75/hour targeted; Commensurate with experience) Employee group: Full Time Schedule: M-F/8:30-5:00 Exempt Status: Non-Exempt Location: Hybrid/School of Medicine Campus Department name: ​​​​​​​SOM Onc Clinical Research Office Personnel area: School of Medicine Equal Opportunity Employer: Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.