Sr. Research Program Coordinator (DOM-Pulmonary)

We are seeking a Sr. Research Program Coordinator who will coordinate multi- and single-center, federally- and industry-funded clinical research studies conducted in the ICU and post-ICU settings for the Division of Pulmonary and Critical Care Medicine. The coordinator will perform, train and / or supervise duties, including consenting, collecting and entering clinical data, and carrying out related research duties for new and ongoing studies based in the ICU. The coordinator will prepare project progress reports, conduct literature searches, assist with manuscript preparation, and provide support for grant applications.

Specific Duties & Responsibilities

• Maintain detailed working knowledge of assigned protocols; design and compile materials which aid investigators and other research staff in complying with protocol requirements.
• Prepare initial protocol submissions, develop consent forms and other regulatory documents in compliance with federal, university, departmental and other regulations
• Serve as the primary point of contact and liaison between PI, research staff, budget office, Office of Research Administration, and other administrative / regulatory areas.
• Coordinate flow of communication between all entities involved in research projects.
• Manage administrative workflow to streamline the execution of contracts / subcontracts and protocol approval processes.
• Participate in study initiation meetings.
• Maintain regulatory binders / spreadsheets for assigned protocols.
• Oversee and conduct recruitment, screening, and enrolling of eligible patients into assigned protocols.
• Verifies patient eligibility for studies. Identifies study participants and is involved in their recruitment process on various clinical trials.
• Obtain informed consent from participants or their legally authorized representatives, explain assigned protocols in detail and conduct informed consent procedures according to required process and protocol eligibility criteria.
• Abstract patient clinical and demographic data from a variety of sources (including paper and electronic medical records multiple electronic platforms) and enter into a CRF, tracking spreadsheet or database.
• Administer standardized surveys to research subjects or their proxies via phone, or via in- patient, clinic or home visits.
• Communicate and collaborate with the PI, treating physician, study coordinators and other members of the study team on an ongoing basis regarding the implementation of the protocol and status of subjects.
• Coordinate investigator meetings, data management meetings, meetings with study investigators and study sub-sites.
• Perform data management and analyses, including advanced use of spreadsheets and databases for studies.
• Ensure accuracy and timeliness of data collection entry, management and analyses.
• Monitor compliance with data quality assurance and quality control goals of clinical studies and follow all written and unwritten study practices, procedures and protocols.
• Prepare and submit changes in research, annual renewals, amendments, and adverse event reports to IRB, DSMB, and sponsor (as applicable).
• Assist in the preparation of IRB, DSMB, and sponsor reports.
• Provide timely data and prompt notification of SAEs, protocol deviations, treatment delays and end of treatment visits.
• Coordinate serious adverse event reporting with the investigators to ensure prompt reporting to the IRB, DSMB, and study sponsor
• Review protocol amendments to identify changes to treatment orders, study calendar and risks to subjects. Lists and clarifies concerns & questions about new protocols with PI and / or sponsor.
• Prepare for and participates in monitoring and audits of studies. Corrects errors in database when necessary. Write responses to audit reports with input from the Principal Investigator.
• Maintain compliance with HIPAA and IRB regulations and guidelines.
• Assist in supervising multiple research staff involved in research activities.
• Prepare weekly reports of activities for supervisor.

Additional Knowledge, Skills, and Abilities

Minimum Qualifications

Preferred Qualifications

Classified Title : Sr. Research Project Coordinator

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

Role / Level / Range : ACRP / 03 / MB

Starting Salary Range : $41,300 - $71,300 Annually ($55,000 targeted; Commensurate with experience)

Employee group : Full Time

Schedule : Monday to Friday 8 : 30am to 5pm

Exempt Status : Exempt

Location : School of Medicine Campus

Department name : SOM DOM Pulmonary

Personnel area : School of Medicine

Total Rewards

The referenced base salary range represents the low and high end of Johns Hopkins University's salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education / training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here : https : / / hr.jhu.edu / benefits-worklife / .

Education and Experience Equivalency

Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines : JHU Equivalency Formula : 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. 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.

Applicants Completing Studies

Applicants who do not meet the posted requirements but are completing their final academic semester / quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks

The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion .

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEOis the Law

https : / / www.eeoc.gov / sites / default / files / 2023-06 / 22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information

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 Talent Acquisition Office at jhurecruitment@jhu.edu . For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https : / / accessibility.jhu.edu / .

Vaccine Requirements

Johns Hopkins University requires all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry.

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.

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.