agencies, and internal quality control of regulatory document management. Responsibilities also include budget and finance related issues.

Specific Duties & Responsibilities

• Assist in study design in collaboration with the Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for clinical trials based on protocol(s).
• Prepare materials for submission to the IRB.
• Work with commercial and/or government agency sponsors and recommend and/or determine what group can commit to considering patient population, available resources, and cost of providing services.
• Participate in developing study budgets.
• Ensure that every clinical research protocol within the program has a completed Prospective Reimbursement Analysis (PRA), and processes/systems are in place ensuring that the PRA is followed when required.
• Assist with budget development and system for tracking and reporting clinical research milestones for financial invoicing.
• Perform self-audits and/or audit other sites.
• Identify opportunities and provide resources to facilitate needed compliance and continuing education for a program.
• Participate in study meetings and provide status updates and recommend changes to operations based on results and goals.
• Conduct literature searches to provide background information.
• Abstract and index information based on knowledge of subject matter.
• Other duties as assigned.

Minimum Qualifications

• Bachelor's Degree in a related field.

• Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.

• Experience managing regulatory affairs.

• Experience in protocol and consent writing, data analysis, grant writing and/or manuscript preparation.

• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Classified Title: Clinical Research Regulatory Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $49,200 - $86,200 Annually ($70,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30-5
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Rad General Administration
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 jhurecruitment@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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

agencies, and internal quality control of regulatory document management. Responsibilities also include budget and finance related issues.

Specific Duties & Responsibilities

• Assist in study design in collaboration with the Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for clinical trials based on protocol(s).
• Prepare materials for submission to the IRB.
• Work with commercial and/or government agency sponsors and recommend and/or determine what group can commit to considering patient population, available resources, and cost of providing services.
• Participate in developing study budgets.
• Ensure that every clinical research protocol within the program has a completed Prospective Reimbursement Analysis (PRA), and processes/systems are in place ensuring that the PRA is followed when required.
• Assist with budget development and system for tracking and reporting clinical research milestones for financial invoicing.
• Perform self-audits and/or audit other sites.
• Identify opportunities and provide resources to facilitate needed compliance and continuing education for a program.
• Participate in study meetings and provide status updates and recommend changes to operations based on results and goals.
• Conduct literature searches to provide background information.
• Abstract and index information based on knowledge of subject matter.
• Other duties as assigned.

Minimum Qualifications

• Bachelor's Degree in a related field.

• Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.

• Experience managing regulatory affairs.

• Experience in protocol and consent writing, data analysis, grant writing and/or manuscript preparation.

• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Classified Title: Clinical Research Regulatory Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $49,200 - $86,200 Annually ($70,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30-5
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Rad General Administration
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 jhurecruitment@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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm