We are seeking a Research Program Coordinator to work under the direct supervision of the Research Program Manager and Clinical Research Supervisor. The Research Program Coordinator (RPC) will be responsible for collection of data on participants who are diagnosed with Chronic Obstructive Pulmonary Disease (COPD), Chronic Bronchitis or Emphysema, and/or Asthma. The RPC will recruit, perform clinic visits which include administering questionnaires, blood draws, spirometry, other breathing tests and biological sample collection. RPC will also be involved in data collection, data quality and abstraction of research data on patients entered into clinic trials and research protocols. This position will provide technical and administrative coordination and support for the lab research studies. Work requires basic use of scientific methods, procedures and techniques.

Specific Duties $ Responsibilities

Recruitment

• Conduct interviews over the phone or in person to determine eligibility for a research study.
• Recruit and screen potential study participants according to inclusion and exclusion criteria; be knowledgeable of the protocol so that study activities are completed correctly and completely.
• Pre-screen potential research subjects for participation in clinical trials and observational studies (including review of medical history, concomitant meds, pathology, and other relevant documents).

Research-related Clinical Tasks

• Coordinate participant visits and follow-up, schedule appointments with study participants, make telephone reminders, send recruitment letters, track and locate participants. Ensure that proper written informed consent from each study participant is obtained prior to entering study; ensure that the original signed and dated consent from each study participant is filed in participant research record and is properly uploaded in Epic, CRMS, RedCap systems and/or any other database collection software system as applicable per research study.
• Perform clinic visits, which include data collection, administering questionnaires, blood draws, spirometry and other breathing and functional tests including sputum collection, and/or urine collection and other biospecimens, as needed.
• Perform routine tests in a research laboratory, help with transportation, storage and shipping of biological samples if necessary.

Research-related administrative tasks

• Design and maintain databases, internal tracking sheets and other organizational tools to conduct current and future studies accurately and in compliance with good research practice.
• Maintain participant follow-up tracking database; maintain records of study participant status by using an enrollment log (if available REDCap platform will be the system to collect research data, to check data quality and to track participant’s visits).
• Track and assess quality and completeness of data entry and abstraction; immediately raise potential concerns with project manager/study PI.
• Document and report progress of research projects.
• Schedule, organize and participate in weekly meetings of current research projects to report progress and resolve problems, taking notes, minutes and preparing agenda for next meetings.
• Assist the research manager/supervisor in tasks related to IRB submissions: change in research, completing progress reports, tracking of renewal dates, completing adverse event forms, writing draft of new forms/surveys.
• Review and assess new protocols for clarity, thoroughness, logistical feasibility, and subject safety. List and clarify concerns and questions about new protocols with PI and/or sponsor.
• Prepare for and participate in study audits. Correct errors in database when necessary. Write responses to audit reports with input from the Principal Investigator.
• Prepare space for study-related equipment and supplies in advance of study visits.
• Coordinate with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. Submit invoices to sponsor.
• Coordinate with Clinical Research Management to identify research billing procedural billing costs and billing accuracy for payment.

Research-related Laboratory tasks

• Proficient in blood and urine processing techniques including centrifugation, plasma/serum pipetting and RBC-depleted cell lysate creation.
• Perform sputum processing including cell solubilization, hemacytomoter use, live/dead cell count and cytospin slide creation
• Operates basic laboratory equipment such as centrifuge, pH meter, analytical balance, incubator, scintillation counter, spectrophotometer, light and confocal microscope, and utilizes laminar flow hood. Operates lab computers for data entry. Proficient in laboratory skills including analytical balance use, tumbling, micropipette and serological pipette use, solution/buffer preparation, and laboratory safety.
• Coordinate receiving of samples and storage logs of all specimens, including use of specified electronic system such as OpenSpecimen.
• Anticipate purchasing needs of the lab, order supplies and research devices as needed or requested using the SAP ordering system and maintain appropriate records for all purchases.
• Create/edit laboratory protocols and forms providing professional expertise in the revision of laboratory standard operating procedures (SOPs) for multiple COPD and asthma studies.
• Prepare source documents for protocol implementation.
• Collaborate with outside companies and other labs.
• Assist coworkers with lab-related details by creating information sheets.
• Streamline all biospecimen storage using Open Specimen.

General

• Is knowledgeable of and complies with Good Clinical Practices, ICH guidelines, sponsor guidelines, University and IRB policies. May instruct introductory level clinical research personnel in these guidelines and policies.
• Work independently and under the direction of the Research Program Manager to ensure successful completion of each clinical research study.
• Serves as the primary point of contact and liaison between PI, research assistants, sponsor of clinical trials, Coordinating center / leading site (for NIH funded studies) and budget office & Office of Research Administration at JHMI.
• Maintain detailed working knowledge of all assigned protocols.

Scope of Responsibility

• Knows the informal policies, procedures and practices necessary to conduct the normal function of a specific section, unit, or work area. Is aware of the role of the position and its potential impact on the working unit.

Decision Making

• 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.

• Bachelor's Degree in related discipline.
• Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

Classified Title: Research Program Coordinator 
Role/Level/Range: ACRO40/E/03/CD  
Starting Salary Range: $17.20 - $30.30 HRLY ($35,776 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: Monday - Friday 8:30am-5pm 
Exempt Status: Non-Exempt 
Location: Johns Hopkins Bayview 
Department name: ​​​​​​​SOM DOM Pulmonary  
Personnel area: School of Medicine