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We are seeking a Sr. Research Program Coordinator who will administratively coordinate multiple protocols for clinical research studies in the Adult Primary Immunodeficiency Center. Primary Immunodeficiencies (PI) are a group of disorders that affect the function of one or more parts of the immune system. This role will collaborate with the research team and sites in the development of research programs.

As part of the clinical program in the Adult Primary Immunodeficiency Center will assist in collecting clinical data regarding patient treatments and evaluations, collect and analyze samples for biobank and databases; and carry out other related duties. Will coordinate research activities and provide support for the Center. The Sr. Research Program Coordinator will prepare project progress reports, conduct literature searches, assist with manuscript preparation, and provides support for grant applications.

Specific Duties & Responsibilities

Research Study Management

• Serve as lead study coordinator for multi-site research study.

• Develop and implement manual of procedures for multiple research protocols.

• Train and oversee research assistants and/or students to comply with study protocol.

• Recruit and screen potential study participants according to protocol’s inclusion and exclusion criteria; be knowledgeable of the multiple protocols so that study activities are completed correctly and completely

• Serve as liaison between multiple collaborators and disciplines, including physicians, APP providers, clinic and institutional administrative staff, pharmacies, and other research partners.

• Responsible for the coordination of services and the communication of pertinent information to all study participants and study partners.

• Assist in the preparation of IRB, DSMB, and sponsor reports.

• Coordinate serious adverse event reporting with the investigators to ensure prompt reporting to the IRB, DSMB (if applicable), and study sponsor.

• Conduct study visits over the phone or in person.

• Ensure proper written informed consent from each study participant is obtained prior to entering study; ensure that the original signed and dated consent from for each study participant is filed in participants’ research record.

• Conduct and track follow-up assessments in a timely fashion. Responsible for troubleshooting participant difficulties with assessment completion.

• Coordinate investigator meetings, data management meetings, meetings with study investigators and study sites and partners, and other study specific meetings.

• Participate in weekly staff meetings to report on recruitment progress. May make recommendations for resolutions to new/outstanding operational issues. May assist in coordinating study(s) meetings, including developing an agenda and reports.

• Work with Principal Investigator and co-investigators to develop recruitment tools and strategies for assigned study(s), which include protocol/study specific data collection forms and study manual of procedures.

• Recruit and screen potential study participants according to protocol’s inclusion and exclusion criteria; be knowledgeable of the protocol so that study activities are completed correctly and completely

• Ensure proper written informed consent from each study participant is obtained prior to entering study; ensure that the original signed and dated consent from for each study participant is filed in participants’ research record.

• Conduct study visits over zoom, the phone, or in person.

• Conduct research visits according to protocols that may include clinical research tests such as spirometry and 6 minute walk tests.

Research Data Management

• Collect research data and manages study databases.

• Conduct and track follow-up assessments in a timely fashion. Responsible for troubleshooting participant difficulties with assessment completion.

• Input, organize, edit, and verify accuracy of data in databases.

• Responsible for requesting and coordinating pharmacy refill records and current medication treatment plans.

• Responsible for tracking, quality control, and cleaning of study devices.

• Track visit completion and manage study procedure concerns and/or issues that arise during visit assessments.

• Responsible for providing Principal Investigator a weekly study status report covering recruitment and retention of participants.

• Will run data queries as requested. May be responsible for providing Principal Investigator a weekly study status report covering recruitment and retention of participants.

• Data analyses responsibilities include analysis of qualitative interviews using a qualitative coding platform. Participating in every stage of the qualitative analysis process from creating a code book, to coding transcripts, to analyzing coded material.

Clinical Program

• Coordinate and provide intellectual contributions to quality improvement projects and related research within the Program

• Assist with literature search and finding, ordering and retrieving published research articles

• Track expenses to assist with budget-related analyses

• Maintain compliance with HIPAA and protect patients’ personal health information.

• Create new data collection forms and revise existing data collection and therapy evaluation forms and progress notes.

• Design and develop an electronic database to store data from collection forms.

• Data entry and management using electronic database and other another computer software.

• Design and perform both routine and ad hoc (customized) data analyses using descriptive statistics and relevant parametric and non-parametric tests

• Design and implement standard and customized reports and presentations, prepared in both text and tabular format, for data analyses and overall project activities

• Ensure that all stored electronic data with PHI meets Johns Hopkins Data Guidelines

• Work with Information Technology personnel regarding the clinical programs databases

• Collect, process and analyze samples for the Center biobank and database

• Organize data and perform calculations to assist with reviewing the outcomes of the project and assist with the preparation of reports and/or manuscripts.

• Coordinate activities and provide support for the Center

General

• Adhere to guidelines regarding the sensitivity and confidential nature of patient information.

• Responsible for writing and editing education procedures, education manuals, and curricula, as needed

• Understand the importance/impact of data integrity regarding honest reporting of sensitive and confidential patient information.

• 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 Senior Research Program Manager and PI to ensure successful completion of the clinical research study.

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.

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

Decision Making

• Carries out duties and responsibilities with limited supervision. Makes decisions and establishes work priorities on essentially procedure-oriented operations.

Supervision

• Will work directly under the supervision of the Senior Research Program Manager and Principal Investigator.

Communication

• Excellent oral and written communication skills and interviewing techniques

Certification

• Required: Will need to complete IRB course work.

Physical Requirements

• Sitting in a normal seated position for extended periods of time

• Reaching by extending hand(s) or arm(s) in any direction

• Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard

• Communication skills using the spoken word

• Ability to see within normal parameters

• Ability to move about

• Ability to attend to information presented one-on-one and during staff meetings.

• Ability to lift 40 lbs.

This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.

*This position is considered non-required attendance but may be asked to work during an event (weather or otherwise) that causes JHU to curtail its operations by closing some or all the university’s offices.

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

Job Posting Title (Working Title): Sr. Research Program Coordinator

Role/Level/Range: ACRP/03/MB

Starting Salary Range:

Employee group: Full Time

Schedule: M-F, 37.5hrs

Exempt Status: Exempt

Location: Johns Hopkins Bayview

Department name: 10002788-SOM DOM Bay Clinical Immunology

Personnel area: School of Medicine

Equal 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.