We are seeking a Sr. Research Program Coordinator to work under the Clinical Research Program Manager of the CRO Coordinating Center. The Sr. Research Program Coordinator is 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. The Sr. Research Program Coordinator is responsible for maintaining compliance of the assigned research studies, including managing study activation related documents and submissions to pertinent regulatory agencies, coordinating database design, approval, and implementation, amendment management, subject eligibility review, and monitoring regulatory and subject compliance for external sites. 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 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.

• Provide education to research staff about coordinating center standards and gives one-on-one guidance to staff in following coordinating centers SOP’s.
• 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.

• 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: $41,300 - $72,300 Annually ($56,800 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F/8:30-5:00 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Onc Clinical Research Office  
Personnel area: School of Medicine