We are seeking a Sr. Research Program Coordinator for the management and coordination of multiple research studies under the general supervision of a faculty investigator. In collaboration with the PI and Research team, coordinate the scientific implementation of research protocols for multiple complex research projects.Specific Duties & Responsibilities
Perform various phenotypic assays, including but not limited to broth microdilution, broth disk elution, and disk diffusion, in order to analyze antibiotic resistance in Gram-negative bacterial clinical isolates.
Analyze and interpret whole genome sequencing data to identify genetic variants and mutations relating to antibiotic resistance.
Compare phenotypic and genotypic assays that have been performed in the laboratory and analyze results.
Conduct quality control procedures to ensure accuracy and reliability of test results.
Assist in the development and implementation of research projects, including data collection and analysis.
Create and maintain research databases tailored to individual projects, ensuring accurate and up-to-date information.
Analyze data for significance to assist with publication preparation.
Draft research manuscripts, peer-reviewed publications, and national laboratory standards documents.
Train new staff members in laboratory techniques and best practices, data collection and management, and documentation requirements.
Present research findings at internal meetings, scientific conferences, and in peer-reviewed publications.
Coordinate and oversee research activities, ensuring adherence to protocols and regulatory requirements.
Facilitate communication and collaboration among research team members, including study sponsors, research staff, and the principal investigator, to ensure study objectives are met on time and within budget.
Host study sponsor representatives on-site for study initiation visits, trainings, progress monitoring, and close out visits.
Assist research staff with receiving or updating their IRB and Good Clinical Practice (GCP) training to ensure compliance with ethical and legal standards for conducting clinical research.
Prepare and submit regulatory documents, including study protocols, staff certifications, and other vital study documents.
Manage and update EDC systems in a timely fashion to guarantee that all study records reflect current progress.
Assemble study instruments and troubleshoot technological issues when necessary.
Serves as de-identifier or sample tester in addition to study coordination as required, providing flexibility from one trial to the next to accommodate for highest need.
Manage receipt and export of shipments for all trial-related activities, including laboratory supplies, biohazardous specimens, dry ice, and study instruments.
Assist with the review and submission of all IRB applications and related documents.
Ensure that all IRB submissions comply with institutional policies and federal regulations.
Monitor and update IRB documentation and procedures to maintain compliance with changing regulations and best practices.
Maintain investigator site files for clinical trials, accounting for all required documents, inventory, and regulatory information in preparation for audits.
Assist with the creation of Material Transfer Agreements to allow for secure collaboration on research projects.
Obtain and renew import permits from the USDA and CDC in order to receive shipments from international clinical trial sponsors.
Improve documentation processes to ensure efficiency, accuracy, and clarity.
Conduct internal audits and reviews to clean up data, correct transcription errors, and guarantee that databases are up to date.
Perform other related duties as assigned.
Special Knowledge, Skills, and Abilities
Strong organizational and analytical skills, problem solving abilities, and attention to detail required.
Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines required.
Ability to coordinate projects independently and work constructively as part of a team required.
Operate personal computer to access email, electronic calendars, and other basic office support software. SAP transactions including order of laboratory supplies (Shopping Cart).
Use various software applications, such as spreadsheets, relational databases, statistical packages, and graphics packages to assemble, manipulate and/or format data and/or reports.
Proficient in Microsoft Word, Excel spreadsheets, PowerPoint presentations, Outlook, electronic calendaring, transcription.
Proficient in spelling and grammar, excellent interpersonal and organizational skills, ability to handle multiple complicated tasks, prioritization skills.
Specific Physical Requirements
While performing the duties of this job, the employee may remain in a stationary position (sitting at computer/desk) up to 85% of the time. The employee is required to operate computer keyboard for majority of work time and other office equipment like calculator or copier throughout the day and for prolonged periods.
Prolonged vision requirements including viewing computer screen, paper reports/documents, and statements.
Role requires daily input and clear/consistent communication, coordination across varied areas necessitating work hours and presence consistent with those the position supports. Ability to interact and communicate with a diverse workgroup.
May transport from one area to another (in the administrative office or building) or be required to lift and/or move up to 40 pounds with proper training, or precautions/lifting aides (example: paper supply boxes, document files, large mail bags/boxes for pick up or receipt). In some areas workspace is confined.
Staff may be required to complete annual competency review, and must ensure compliance with Hospital Policy, Laboratory Policy & Procedure, Health, Safety & Environment regulations, and all applicable privacy & confidentiality laws/practices.
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 CoordinatorRole/Level/Range: ACRP/03/MBStarting Salary Range: $41,300 - $72,300 Annually ($60,000 targeted; Commensurate with experience)Employee group: Full TimeSchedule: M-F 8:30am – 5:00pmExempt Status: ExemptLocation: School of Medicine CampusDepartment name: SOM Ped Infectious DiseasePersonnel area: School of MedicineEqual 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.