Classified Title: Consent Form Specialist Working Title: Consent Form Specialist Role/Level/Range: ATP/04/PC Starting Salary Range: $50,200 - $69,089 Employee group: Full Time Schedule: M-F 8:30 a.m. - 5:00 p.m. Exempt Status: Exempt Location: 1630 McElderry St. Department name: 10002712-SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine
The Consent Form Specialist (CFS) 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.
The position will work under the supervision of the Lead Senior Consent Form Specialist and report to the OHSR Director of Operations. The CFS will work closely with IRB members, IRB Analysts and Coordinators, the Assistant Dean for Human Research Protections, Office of Research Administration and study team members.
Duties & Responsibilities
Independently 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.
Attend weekly IRB meetings to provide advice on consent documents and make changes requested by the IRB prior to release of the consent documents.
Act as a liaison between faculty/staff and the IRB to ensure appropriate application-specific documents are submitted for the category of consent requested (e.g., verbal, written and waiver of consent).
Examine consent documents to ensure required and optional elements are present as mandated by regulations.
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. Also consults with Clinical Research Support Services regarding Prospective Reimbursement Analysis (PRA) and compares 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.
Provide clear and detailed consent form guidance in response to PI/study team telephone/email inquiries
Bachelor's degree from accredited 4-year college is required. Requires a minimum of 3 years of experience writing/editing medical or pharmaceutical documents or consent forms. Graduate level training may substitute for up to two years of experience.
Master's degree preferred.
Special knowledge, skills, and 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 is desirable.
Excellent grammar, spelling, and accuracy in proofreading and attention to detail.
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.
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.
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.
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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