Specific Duties & Responsibilities

• Collaborate with PI and study team to ensure operational feasibility of proposed protocol/study design.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for studies based on protocol(s).
• Prepare materials for submission to IRB and follow-up on regulatory issues.
• Train and provide oversight of research data management and regulatory issues.
• Work with commercial and/or government agency sponsors to recommend and/or determine what group can commit to considering patient population, available resources, and cost of providing services.
• Work with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
• Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA), and processes/systems are in place to ensure the PRA is followed when required.
• Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
• Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to clinical trials.
• Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
• Organize and quality control study data.
• Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial.
• Perform self-audits and/or audit other sites.
• Participate in study meetings to present data, provide status updates, recommend changes to protocol operations based on results and goals, and suggest ideas for sub-studies.
• Extract data, review literature, and assist with preparation of manuscripts and presentations as appropriate.
• May oversee day-to-day activities and provide training for study staff.
• Other duties as assigned.

In addition to the duties listed above

• Coordinate day-to-day administrative and operational activities for RCCS, IN-STEP, SENTINEL, and other CCGHE-ID/RHSP-related research studies.
• Maintain regulatory files and track approvals, expirations, and required submissions across Johns Hopkins, RHSP, and collaborating institutions.
• Serve as a central point of contact for investigators, RHSP staff, laboratories, and collaborators to support communication and follow-up.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Five years of related experience.
• 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.

Preferred Qualifications

• Master's Degree in a related field.

Classified Title: Sr. Clinical Research Coordinator II
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $49,200 - $86,200 Annually (Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday to Friday 5:30am - 5pm
FLSA Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Infectious Disease
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

Specific Duties & Responsibilities

• Collaborate with PI and study team to ensure operational feasibility of proposed protocol/study design.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for studies based on protocol(s).
• Prepare materials for submission to IRB and follow-up on regulatory issues.
• Train and provide oversight of research data management and regulatory issues.
• Work with commercial and/or government agency sponsors to recommend and/or determine what group can commit to considering patient population, available resources, and cost of providing services.
• Work with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
• Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA), and processes/systems are in place to ensure the PRA is followed when required.
• Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
• Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to clinical trials.
• Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
• Organize and quality control study data.
• Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial.
• Perform self-audits and/or audit other sites.
• Participate in study meetings to present data, provide status updates, recommend changes to protocol operations based on results and goals, and suggest ideas for sub-studies.
• Extract data, review literature, and assist with preparation of manuscripts and presentations as appropriate.
• May oversee day-to-day activities and provide training for study staff.
• Other duties as assigned.

In addition to the duties listed above

• Coordinate day-to-day administrative and operational activities for RCCS, IN-STEP, SENTINEL, and other CCGHE-ID/RHSP-related research studies.
• Maintain regulatory files and track approvals, expirations, and required submissions across Johns Hopkins, RHSP, and collaborating institutions.
• Serve as a central point of contact for investigators, RHSP staff, laboratories, and collaborators to support communication and follow-up.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Five years of related experience.
• 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.

Preferred Qualifications

• Master's Degree in a related field.

Classified Title: Sr. Clinical Research Coordinator II
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $49,200 - $86,200 Annually (Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday to Friday 5:30am - 5pm
FLSA Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Infectious Disease
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