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We are seeking a Sr. Research Program Coordinator who, under minimal supervision, will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. Will serve as a central resource for faculty conducting clinical research. Preferred candidates should demonstrate excellent communication and organizational skills and the ability to work well independently. Working closely with the Program Manager, Start-up Specialist, Research Nurse and Program Coordinators, this position will assist with the initial IRB submission. Prior to the start of a study, will ensure all proper regulatory documents have been approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed. Will produce and maintain a regulatory binder prior to the study starting with all required documents and additional sections for future documents. Works closely with the Program Coordinators to ensure all documents are submitted to the IRB in a timely manner.

Specific Duties & Responsibilities

• Work closely with the research Nurse, PI and study coordinators on protocol amendments to ensure timely, accurate submission to the IRB and sponsors.

• Assure investigator-initiated protocol amendments have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.

• Assist Development of Red Cap database for investigator-initiated studies prior to study activation.

• Obtain all required documents for protocol amendments for the IRB.

• Submit and track each protocol amendment through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.

• Assists the Start Up Specialist with new study IRB submissions as needed.

• Ensures smooth study activation by working closely with the Startup Specialist, PI, research RN and program coordinators to collect all regulatory documentation.

• For IND studies, maintain accurate and up-to-date documents and protocol amendment submissions.

• Produce and maintain a regulatory binder prior to study starting with all required documents.

• Work closely with all sponsors to ensure all regulatory documents are reviewed, approved and correct prior to a study opening.

• Ensure all documents are being collected in a timely manner and all regulatory binders are up to date. Meet with Program Coordinator and research assistant to review all documents prior to study activation.

• Participates in 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.

• Assist Program Coordinators and Assistants in preparation and conduct of monitoring visits.

• Maintain a continued high level of expertise in institutional databases including Epic, EPR, OnCore, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.

• Participate as requested in Cancer Center events such as training and orientation for testing of OnCore database updates and modules.

• Attend monthly CRO Regulatory Specialist meeting.

• 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.

Minimum Qualifications

• Bachelor's Degree in related discipline.

• Three years related experience.

• Additional education may substitute for experience.

Preferred Qualifications

• Master's Degree preferred.

• Certification as a Clinical Research Professional is preferred.

Classified Title: Sr. Research Program Coordinator

Job Posting Title (Working Title): Sr. Research Program Coordinator

Role/Level/Range: ACRP/03/MB

Starting Salary Range: $40,900 - $71,600 Annually (Commensurate with experience)

Employee group: Full Time

Schedule: M-F, 830-500

Exempt Status: Exempt

Location: Hybrid: On-site 3-4 days a week

Department name: 10002941-SOM Onc Urologic Oncology

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.