Sr. Research Program Coordinator, COVID-

General Summary/Purpose

TheResearch NavigatorCoordinator (RNC) willprovideadministrativesupporttotheinpatient and outpatient COVID-19 research effort at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center. Thisposition willprimarily assistinvestigators who are conducting research studies in COVID-19 by connecting them to resources and, where appropriate, suggest new processes to help streamline implementation. The RNC willwork with the ICTR Research Navigators to provide basic regulatory and project management supportfor COVID-19 research and associated efforts.

The RNC will organize recruitment efforts for COVID-19 research studies in the inpatient and ambulatory settings working with the Recruitment Innovation Unit (RIU) to help create an efficient and effective COVID research screening and recruitment process. The RNC will interact with study teams and research participant candidates either in person or remotely to present study options and connect interested candidates with study teams. The RNC will monitor and use MS Teams for COVID Recruitment and centralized email addresses to connect with research participant candidates and study teams.

The RNC will create, organize and manage a Microsoft Teams for Frequently Asked Questions (FAQs) surrounding COVID research during all stages of the research (study start up, implementation, and ongoing study activity efforts). The RNC will also manage and oversee a Microsoft Teams that oversees COVID research recruitment. The RNC will be responsible for managing communication will study teams, and also ensure that all COVID research groups are using the Microsoft teams group. The RNC will be expected to stay up to date on all policies and procedures surrounding clinical research, but leveraging not only their own knowledge and research, but all the knowledge and resources from their colleagues throughout the ICTR and the SOM.

The RNC will work closely with the Research Nurse Manager of the COVID-19 Clinical Research Units and with the COVID Operational Manager to ensure smooth implementation of upcoming proposed research studies. The RNC will be responsible for overseeing all currently enrolling studies to track enrollment and study schedule. The RNC will utilize the guidance of the Research Nurse Manager of the COVID-19 Clinical Research Units, and the COVID operational Manager in order to help study teams coordinator study activities to maximize staff efficiency and also decrease participant burden when possible.

Writingand reviewing correspondence and communicating with patients who might be critically ill arecentraltothisposition,soexcellentwritten and verbalcommunicationskillsand attentiontodetailareessential. Thispersonmust alsohavethewillingnessandabilitytolearn thepurpose,processesand proceduresofcomplexprogramsandworkflows,asheorshemustattainabasicunderstandingofallICTRprograms,servicesandresources. Organizational skills, acute independent judgement, and the ability to be a self-starter and team player are needed to be successful in this position as the RNC will be responsible for helping to coordinating many aspects of the startup and implementation of COVID research, while also making sure to stay up to date on all relevant COVID related Institutional, FDA, CDC, etc. changes in policies or guidance.

Specific Duties & Responsibilities

• Implement strategies to execute COVID-19 clinical research protocols.
• Work closely with other colleagues to review and update COVID strategies as needed to ensure effective and efficient COVID research.
• Provide, as an ICTR-provided centralized resource, direct support to investigators and study team members to ensure safe study conduct in the setting of potentially highly infectious pathogens and the rapidly-changing requirements surrounding this specialized area of research. Develop and maintain standard operating procedures, in collaboration with ambulatory services and HEIC, provide maximum safety for research teams and participants.
• Develop and manage the COVID research Frequently Asked Questions (FAQ’s) Microsoft Teams Group.
• Develop centralized recruitment efforts for COVID research working with the RIU team.
• Review and assess COVID recruitment. Track recruitment efforts across all COVID teams and report regularly on recruitment numbers, reasons for participants declining participation, and improvements to the recruitment process
• Communicate regularly with COVID stakeholders to identify problems and roadblocks in COVID research and work with colleagues to suggest solutions and implement new processes to improve the efficiency of COVID research
• Communicate regularly with COVID research teams to ensure that they are being supported in an effective way. If research teams the RPN will gather those suggestions and present them to the COVID committee as appropriate.
• Oversee COVID participant research schedules to help study teams coordinate sample collections to ensure that participant burden is minimized as much as possible.
• Work with study teams to schedule intrastaff or other clinical resources as appropriate to ensure appropriate and timely research sample collection.
• Provide guidance and support for COVID research teams when urgent issues arise. Will work will other COVID research colleagues to address these issues in a timely, safe, and ethical manner, following best practices when they are applicable.
• Track all urgent COVID research issues and how they were resolved so that other teams can learn from previous COVID research issues.
• Maintain a thorough knowledge and understanding of :
• All resources and programs within the ICTR and institution that are currently available to assist research teams
• The policies and procedures for approving and implementing clinical research protocols
• Institutional and federal biosafety requirements for preclinical and human research

• Maintains metrics as required by ICTR leadership to evaluate designated COVID research aspects. Will also assist with developing the methods for conducting these evaluations.
• Assist investigators and study team members with finding training for the various network processes and procedures used to conduct clinical research at JHMI (i.e. eIRB, EPIC, CRMS)
• Assist investigators and study team members with staying up to date on all COVID research changes in guidance and regulations (both institutionally and at the federal level).

Minimum Qualifications(Required)

• Bachelor’s Degree in related discipline required.
• Three (3) years in related experience required.

Additional education may substitute for required experience, to the extent permitted by theJHU Equivalency Formula:18 graduate degree credits may substitute for one year of experience. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Preferred Qualifications:

Master’s degree preferred. Advanced education may substitute for some years of experience.

Experience in clinical research at an academic, government, or pharmaceutical industry environment preferred.

Experience in the following areas is preferred: translational research, regulatory affairs, clinical trials, project management, and team-building.

Bachelor’s degree with course work in science or health care administration required.

Within Hopkins environment, this could be equivalent to three years of experience working as a Sr. Research Program Coordinator I, II, or Research Program Manager, for instance.

Special Knowledge, Skills, and Abilities

Strong organizational skills

• Ability to manage multiple and competing priorities
• Ability to work independently as well as with various research teams
• Effective interpersonal skills: must be an outgoing self-starter who can comfortably work with physicians and staff and get things done
• Excellent time management skills
• Excellent attention to detail
• Excellent oral and written communication skills
• Proficiency in the use of software applications, databases, spreadsheets, and word processing required.

• Must have a working knowledge of federal regulations pertaining to clinical trials, research (FDA, OHRP), and good clinical research practices and principles (GCP).
• Must adhere to policies related to protecting and reporting of sensitive and confidential patient information. Must understand the importance and impact of data integrity in terms of patients, study results, costs, quality of service, and scientific research in general. Regular contact with physicians, other health care personnel requires the use of good judgment, tact, and sensitivity.
• This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.

Certification as a Clinical Research Professional and certification by the Regulatory Affairs Professionals Society are both desirable.

Sitting in a normal seated position in office setting

Standing and/or walking for extended periods of time

Lifting and/or assisting patients during evaluations within crowded clinical environment

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 hear within normal range

Ability to move about.

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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