Sr. Research Program Coordinator II

Under limited supervision of the Clinical Research Program Manager, we are seeking a Sr. Research Program Coordinator II who will be responsible for study site activation and management, including regulatory review, site study team training, data monitoring and integrity management, patient enrollment, and overall project timeline management for the Genitourinary Oncology Clinical Research Program. This requires a high level of knowledge, oversight, and organization, and will serve as a central resource for faculty conducting clinical research. Responsibilities will also include orient and train research staff in the program and assist with general operations of the program.

Specific Duties and Responsibilities

• Assists the Start Up Specialist new study IRB submissions as needed.
• Ensures smooth study activation by working closely with the start up specialist, PI and research RN and collecting all regulatory documentation.
• Work closely with the Protocol compliance team to ensure all documents are ready prior to a study opening.
• Produce and maintain a regulatory binder prior to study starting with all required documents.
• Work closely with sponsors to ensure all regulatory documents are reviewed, approved and correct prior to a study opening.
• Ensures all documents are being collected in a timely manner and all regulatory binders are up to date. Meets with Program Coordinator and data assistant to review all documents prior to study activation.
• Establishes regular meetings with PI, research RN and study coordinator to discuss protocol amendments, deviation and AE logs and patient updates.
• Assist CRO in the auditing and monitoring of studies, including external sites.
• Work closely with the Research Nurse, PI and study coordinators on protocol amendments to ensure timely, accurate submission to the IRB and sponsors.
• Obtain all required documents for protocol amendments to the IRB. And assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
• Tracks each protocol amendment through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
• Coordinate the conduct of multicenter clinical trial protocols, including study site selection and activation, patient enrollment, electronic case report form design, specimen shipping, data monitoring, safety review, and other protocol-related tasks.
• Assist with protocol development and revision of investigator-initiated multicenter studies: Assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
• Track each site through local regulatory review and contract execution process, evaluate for recurrent problems, development and implement systems to decrease delay in site activation process.
• Collect and review regulatory documents from participating sites prior to study activation, conduct study start-up meetings, maintain communication with sites to ensure high quality of data, timely submission of data, and adherence to guidelines.
• Review subject eligibility and registration request.
• Conduct on-site training and monitoring visits as needed.
• For IND studies, maintain accurate and up-to-date documents and submissions.
• Facilitate the full cycle of the protocol approval process - development, submission, contract negotiation, budget development, interaction with Cancer Center Cores.
• Assist PI with abstracts and manuscripts preparation.
• When needed, recruit and train research data management and regulatory personnel within the Program.
• Provide training and preceptorship to Senior Coordinators specifically with Writing Lab Manuals, Creating Database CRFs, Assist Program Manager with Budget creation, Conducting monitoring visits, and writing monitoring reports.
• Provide checklist of regulatory and essential documents and ensure these are maintained in e-reg binder for JHU.
• Monthly review monitoring reports for each site along with the deviation log for all sites.
• Maintain a continued high level of expertise in institutional databases including Epic, CRMS, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
• Assist Clinical Research Program Manager with program operations - providing suggestions for improved procedures, creating checklists and program-related Standard Operating Procedures.
• Participate as requested in Cancer Center events such as training and orientation for new research staff, testing of CRMS database updates and modules.
• Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies.
• Ensure that Cancer Center policies, Standard Operating Procedures, and guidelines related to the conduct of clinical trials are followed.

• Bachelor's Degree in related discipline. Related Master's preferred.
• Five years related experience

Classified Title: Sr. Research Program Coordinator II
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $48,000 - $84,100 Annually ($70,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30-5:00
FLSA Status:Exempt
Location:Hybrid/School of Medicine Campus
Department name: SOM Onc Urologic Oncology
Personnel area: School of Medicine