We are seeking a Sr. Research Program Coordinator who will coordinate the activities of a multi-center clinical research study, including preparing IRB application and materials, collaborating with the research team to develop research instruments and forms, screening and recruiting eligible patients for study participation, collecting research data and managing study databases, preparing reports, conducting literature searches, and assisting with grant and manuscript writing.

Specific Duties & Responsibilities

• Prepare IRB applications, including the informed consent and recruitment materials.
• Develop and implement manuals of procedures and standard operating procedures.
• Assist in database development and testing.
• Assist in creating forms and other study-related materials.
• Recruit and screen potential study participants according to protocols’ inclusion and exclusion criteria; be knowledgeable of the protocols to ensure proper completion of study activities.
• Conduct study visits over the phone, in person, or through a web-based platform.
• Ensure proper written informed consent from each study participant is obtained; ensure that the original signed and dated consent form for each study participant is filed in the participants’ research record. Maintain clinical site research study master files.
• Conduct assessments per protocol. Monitor visit and survey completion, inform participants of upcoming scheduled clinic and research appointments, troubleshoot patient difficulties arising during visit assessments, and manage concerns/issues about study procedures. Report adverse events. Register and pay participants through an established electronic system.
• Liaise between multiple collaborators and study team members, including physicians, clinic administrative staff, and pharmacies locally and at participating clinical sites around the country. Be responsible for the coordination of services and the communication of pertinent information to study participants.
• Participate in weekly staff meetings to report on recruitment progress and study-related issues. Recommend resolutions to new/outstanding operational issues. Assist in coordinating study-related meetings, including developing an agenda and reports and taking minutes. Track completion of action items.
• Assist in preparing DSMB, and sponsor reports as needed. Run data queries as requested and provide routine study status reports.
• Abstract data from archival audio, paper, and/or electronic records, such as pharmacy refill records and medical record abstraction. Input, organize, edit, and verify data accuracy in databases. Responsible for data tracking and quality control. Follow up with clinics on outstanding data queries. Audit records as needed.
• Maintain tracking systems and coordinate distribution of devices, parking vouchers, payment cards, and other study supplies.
• Train, and oversee research assistants and/or students as applicable.
• Support the Research Program Manager and Principal Investigator in tasks as needed.
• Adhere to guidelines regarding the sensitivity and confidential nature of patient information and data quality guidelines.
• Exercise good judgment, tact, and sensitivity at all times while working in a busy hospital clinic environment.
• Work independently and under the direction of the Research Program Manager to ensure successful completion of the clinical research study.

Communication

• Excellent oral and written communication skills and interviewing techniques.

Experience

• Ability to work independently and manage multiple tasks, detail-oriented, self-motivated, strong interpersonal skills; ability to use a personal computer; proficiency in Microsoft Word and Excel; database and spreadsheet knowledge.

Certification

• Will need to complete IRB coursework.

• 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 
Employee group: Full Time 
Schedule: Monday - Friday 8:30am to 5pm 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: SOM DOM Pulmonary  
Personnel area: School of Medicine