Inside Higher Ed
Sr. Clinical Research Coordinator
Inside Higher Ed, Baltimore, Maryland, United States, 21276
Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a
Sr. Clinical Research Coordinator
who will oversee the day-to-day activities of a single complex study (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites, study for which Hopkins is a coordinating center) or multiple clinical research studies and makes independent decisions that impact the conduct of the research. Assists in goal setting and creating implementation plans. Contributes to budget formulation, communications, and data systems.
Specific Duties & Responsibilities
Assist Principal Investigator or more senior research staff 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 clinical trials based on protocol(s).
Prepare materials for submission to IRB.
Contribute to work with commercial and/or government agency sponsors and recommend which group can commit to considering patient population, available resources, and cost of providing services.
Ensure compliance with all protocols, procedures, and applicable regulations.
Participate in developing the study budget.
Develop and oversee the implementation of recruitment strategy for participants for one or more assigned studies.
Set up a data collection system and ensure the validity of study data.
Organize and quality control study data.
Perform self-audits and/or audit other sites.
Participate in study meetings and provide status updates and recommend changes to protocol operations based on results and goals.
Conduct literature searches to provide background information.
Additional Duties & Responsibilities
Collaborate with the Alzheimer's Anti amyloid Treatment (AAT) program director to track and manage program operations.
Schedule and facilitate meetings, including agendas and minutes (e.g., AAT program meetings, seminars).
Serve as the central coordination point between patients, memory clinic, radiology, and infusion services.
Monitor and support patient satisfaction throughout treatment.
Learn and assist with phlebotomy (preferred but not mandatory).
Create PowerPoint presentations to communicate clinical and program updates.
Track and compile publications, presentations, and grants for quarterly reporting.
Minimum Qualifications
Bachelor's Degree in a related field.
Three years of related experience.
Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
Master's Degree in a related field.
Technical Skills And Expected Level Of Proficiency
Budget Management - Developing
Clinical Research Participant Recruitment - Developing
Clinical Study Design - Developing
Clinical Trial Management System - Developing
Data Management and Analysis - Developing
Data Collection and Reporting - Developing
Good Clinical Practices - Developing
Interpersonal Skills - Developing
Project Management - Developing
Regulatory Compliance - Developing
Report Writing - Developing
Classified Title: Sr. Clinical Research Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $72,300 Annually ($50,000 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: M-F 8am - 5pm FLSA Status: Exempt Location: Johns Hopkins Bayview Department name: SOM Psy Bay Bayview Physicians Personnel area: School of Medicine
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.
EEO is 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/.
Vaccination requirements: Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and 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.
This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status.
For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.
#J-18808-Ljbffr
Sr. Clinical Research Coordinator
who will oversee the day-to-day activities of a single complex study (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites, study for which Hopkins is a coordinating center) or multiple clinical research studies and makes independent decisions that impact the conduct of the research. Assists in goal setting and creating implementation plans. Contributes to budget formulation, communications, and data systems.
Specific Duties & Responsibilities
Assist Principal Investigator or more senior research staff 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 clinical trials based on protocol(s).
Prepare materials for submission to IRB.
Contribute to work with commercial and/or government agency sponsors and recommend which group can commit to considering patient population, available resources, and cost of providing services.
Ensure compliance with all protocols, procedures, and applicable regulations.
Participate in developing the study budget.
Develop and oversee the implementation of recruitment strategy for participants for one or more assigned studies.
Set up a data collection system and ensure the validity of study data.
Organize and quality control study data.
Perform self-audits and/or audit other sites.
Participate in study meetings and provide status updates and recommend changes to protocol operations based on results and goals.
Conduct literature searches to provide background information.
Additional Duties & Responsibilities
Collaborate with the Alzheimer's Anti amyloid Treatment (AAT) program director to track and manage program operations.
Schedule and facilitate meetings, including agendas and minutes (e.g., AAT program meetings, seminars).
Serve as the central coordination point between patients, memory clinic, radiology, and infusion services.
Monitor and support patient satisfaction throughout treatment.
Learn and assist with phlebotomy (preferred but not mandatory).
Create PowerPoint presentations to communicate clinical and program updates.
Track and compile publications, presentations, and grants for quarterly reporting.
Minimum Qualifications
Bachelor's Degree in a related field.
Three years of related experience.
Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
Master's Degree in a related field.
Technical Skills And Expected Level Of Proficiency
Budget Management - Developing
Clinical Research Participant Recruitment - Developing
Clinical Study Design - Developing
Clinical Trial Management System - Developing
Data Management and Analysis - Developing
Data Collection and Reporting - Developing
Good Clinical Practices - Developing
Interpersonal Skills - Developing
Project Management - Developing
Regulatory Compliance - Developing
Report Writing - Developing
Classified Title: Sr. Clinical Research Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $72,300 Annually ($50,000 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: M-F 8am - 5pm FLSA Status: Exempt Location: Johns Hopkins Bayview Department name: SOM Psy Bay Bayview Physicians Personnel area: School of Medicine
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.
EEO is 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/.
Vaccination requirements: Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and 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.
This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status.
For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.
#J-18808-Ljbffr