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 Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $72,300 Annually ($60,000 targeted; Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30am - 5:00pm Exempt Status:Exempt Location:School of Medicine Campus Department name: SOM Ped Infectious Disease Personnel area: School of Medicine
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