Under the direct supervision of the Research Program Manager or the Program Principal Investigator, we are seeking a Research Program Coordinator (RPC) who will be the primary coordinator for multiple NIH, industry, and Johns Hopkins initiated research projects. The RPC will be responsible for all aspects of implementation including screening and recruiting eligible patients; scheduling and completing study visits and/or telephone calls, which include remote data capture and/or qualitative interviews; managing local study databases; preparing reports; and conducting other study-related procedures. The RPC will also be responsible for organizing and completing case report forms (CRFs); data entry; maintenance and accuracy of all participant clinical and research data and billing, in a timely and ongoing manner. Additional responsibilities include coordinating with other research teams in a multi-center consortium, including collaborating on the development of study protocols, manual of procedures, and electronic CRFs; and conducting literature searches.

Specific Duties & Responsibilities

• Build and maintain working relationships with personnel at study recruitment sites. Work closely with and support other study staff.
• Follow common study recruitment strategies as outlined in the research protocol, which include sending out recruitment letters and brochures, reviewing medical charts, and/or approaching potential study candidates. Recruit and screen potential study participants according to protocols' inclusion and exclusion criteria; ensure proper informed consent from each study participant is obtained using the most current IRB-approved consent forms; ensure that the original written consent form is filed in participants' research record or that verbal consent is properly documented, as applicable to the protocol.
• Maintain local research site study master files. Be knowledgeable of the protocols to ensure proper completion of study activities. Design and utilize protocol specific report forms and source documents.
• Liaise between multiple collaborators and study team members, including physicians, clinic administrative staff, external collaborators, and/or vendors. Be responsible for coordinating and communicating pertinent information to study participants.
• Schedule and remind participants of upcoming research appointments; coordinate research staff schedules to ensure availability to complete research activities as needed. Manage and maintain detailed log of participant payments.
• Conduct research assessments and semi-structured interviews in a timely fashion via phone, mail, in-person, or by web-based platform. Monitor visit and survey completion; troubleshoot difficulties that may arise with completing research data collection; and manage concerns/issues about study procedures.
• Input, organize, edit, and verify accuracy of data in databases. Run data queries as requested and provide routine study status reports.
• Establish and maintain study regulatory binders and charts for each participant.
• Meet regularly with the research team for review of data accuracy and overall progress; report on recruitment and study-related issues.
• Collect biological specimens (urine samples), blood pressure measurement and other clinical measures. Coordinate and participate in regularly scheduled meetings and conference calls with the study team; study collaborators; community advisory board members (CAB); and data and safety monitoring board (DSMB); develop meeting agendas in collaboration with the PI
• Coordinate adverse event reporting with the investigators and ensure prompt reporting to the Institutional Review Board (IRB).
• Adhere to guidelines regarding the sensitivity and confidential nature of patient information and data quality guidelines.
• Exhibit high level of organization, time management skills and ability to work on multiple projects simultaneously, while being able to prioritize and establish/meet deadlines
• Assist in preparing IRB, DSMB, CAB, and sponsor reports. Participate in required training sessions.
• Collaborate with project team on presentations, manuscripts and grants related to project data.
• Work independently and under the direction of the Research Program Manager to ensure successful completion of the clinical research study. Support the Research Program Manager and Principal Investigator in study-related tasks as needed.

Special Knowledge, Skills, & Abilities

• Understanding of research methodology, IRB, and GCP.
• Excellent oral and written communication skills and interviewing techniques. Ability to communicate with a wide variety of individuals including study participants, administrative. personnel, PIs, experienced clinicians and physicians.
• Detail oriented, strong interpersonal skills and excellent organizational and time management skills required. Carries out duties and responsibilities with limited supervision, but asks for clarification when needed regarding data quality and integrity issues and promptly notifies supervisors of any potential concerns regarding interactions with patients.
• Ability to function autonomously as part a collaborative interdisciplinary team.
• Problem-solving skills, ability to think quickly and implement plans/structure for accomplishing work.
• Technical Qualifications or Specialized Certifications
• Required: All IRB-required courses, appropriate study related certifications/training must be completed within 2 weeks of start date.

• Bachelor's Degree in related discipline.
• Additional related experience may substitute for required education, tothe extent permitted by the JHU equivalency formula.
• Proficient in Microsoft programs (Word, Excel, Outlook, etc.); additional computer skills including navigating the internet and websites
  

• Strong computer and video/phone technology skills; knowledgeable about using database programs (such as REDCap) for data queries and producing routine reports.

• Experience with social and behavioral health interventions and/or qualitative research, preferred.
• Experience with multi-center studies preferred.
• Bilingual English-Spanish speaking preferred.

Classified Title: Research Program Coordinator
Job Posting Title (Working Title): Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 hourly ($45,000 budgeted; commensurate with experience)
Employee group: Full Time
Schedule: Mon-Fri 8 hours per day
Exempt Status: Non-Exempt
Location: Hybrid/School of Medicine - East Baltimore Campus
Department name: SOM DOM Nephrology
Personnel area: School of Medicine