The Office of Human Subjects Research is seeking a Consent Form Specialist (CFS) who supports the JHM Institutional Review Boards (IRBs) with regard to appropriate documentation, and compliance with federal, state and local regulations concerning informed consent for research participants. Support is provided for all human research activity conducted at or through JHM, and researchers at non-Hopkins sites relying on the review of the JHM IRBs. This position will be assigned as primary consent form specialist support to the JH-ACH IRB.
Specific Duties & Responsibilities:
Attend IRB meetings to provide advice on consent documents [including consent forms, oral consent scripts and recruitment materials and make changes requested by the IRB prior to release of the consent documents.
Evaluate consent form documents submitted with applications for human subjects research to determine the consistency of the document with the scope of the work proposed, and compliance with federal, state and local regulations for protection of human subjects.
Act as a liaison between faculty/staff and the IRB to ensure that appropriate application-specific documents are submitted for the category of consent requested (e.g., written and waiver of documentation of consent).
Process consent elements review for applicable expedited applications.
Process external IRB applications to ensure all local consent requirements have been addressed.
Process sIRB studies where JHM is the reviewing IRB, including pSite consent creation.
Revise and rewrite consent form documents for clarity, accuracy and readability. Assess reading level and complexity of consent documents to determine appropriateness of use in the targeted population.
Consult with the Human Subjects Research Compliance staff to ensure regulatory requirements for consent documents are being met.
Consult with the Office of Research Administration for required information from Master Clinical Agreements (contracts) that must be included in consent form documents. This includes the specific injury coverage for research participants in a given study.
Consult with Clinical Research Support Services regarding the Prospective Reimbursement Analysis (PRA) and compare the PRA with the protocol/application for consistency.
Work with the Clinical Radiation Research Committee and the Radioactive Drug Research Committee to confirm the correct radiation exposure language is in the consent form.
Contribute to the development of consent-related educational materials and participate in trainings where these materials are discussed.
Remain knowledgeable about consent issues through participation in webinars, lectures, national conferences, and other continuing education.
Provide clear and detailed consent form guidance in response to PI/study team telephone/email inquiries.
Conduct administrative and regulatory review of designated human subjects research application submissions
Determine level of review appropriate for research submission.
Advise & assist investigators and their staff regarding submission of applications in accordance with institutional policy, federal, state, and local regulations governing human subjects research.
Serve as a back-up to the dedicated JH-ACH IRB Coordinator/Analyst to provide coverage for convened meetings including recording of IRB meeting minutes in keeping with current policies and procedures.
Serve as a back-up for other consent form specialists in support of the activities of other JHM IRBs.
Other duties as assigned.
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis.
Minimum Qualifications (Mandatory):
Bachelor's Degree from accredited 4-year college is required. Master's Degree preferred.
A minimum of 3 years of experience relevant to human research studies desirable.
Special Knowledge, Skills & Abilities:
Possess knowledge of Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations for human research studies, and understands the differences in consent requirements between the two sets of regulations.
Proficiency in PC operation and ability to use word processing, databases and spreadsheet software.
Experience in writing consent forms or in consenting research participants is desirable.
Excellent grammar, spelling, and accuracy in proofreading and attention to detail.
This position has been designated as a remote position.
On-site attendance may be required for select meetings or events.
Advanced notice will be provided for these circumstances.
The position will report directly to the IRB Program Manager at JH-ACH. The CFS will work closely with IRB members, IRB Analysts and Coordinators, IRB Compliance Associates, IRB Associate Director of Operations, IRB Director of Operations, the Associate Dean for Human Research Protections, Office of Research Administration and study team members.
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 hear within normal range.
Ability to move about.
Classified Title: Consent Form Specialist Working Title: Consent Form Specialist (JH - ACH) Role/Level/Range: ATP/04/PC Starting Salary Range: $51,210 - $70,480 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30 a.m. - 5:00 p.m. Exempt Status: Exempt Location: FL - Florida Department name: SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine
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 at firstname.lastname@example.org. 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.
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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