Johns Hopkins University Research Program Assistant II in Baltimore, Maryland
The Division of Hematology is seeking a Research Program Assistant II who will work under the direct supervision of the Clinical Research Program Manager and will be responsible for monitoring and collecting research data for complement associated diseases in the Division. The Research Program Assistant II is responsible for the organization, entry, maintenance and accuracy of clinical research data for complex and detailed clinical trials.
This role will help with consenting, collecting research samples and delivering them to the lab, and helping to prepare monthly data reports to the PI and collaborating investigators. They may collaborate in development and writing of protocols and consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns and questions about new protocols with PI and Sponsor. This is an entry level position in managing research trials and registry databases within the research program.
Specific Duties & Responsibilities:
Supportsrecruitment,screeningand enrolling of eligible patients into laboratoryprotocols.
Explain the protocol in detailandconductinformedconsentprocedures with potentialresearchparticipants.
Maintaingood working knowledge of allassignedprotocolsandreportingrequirements. Work on complexclinicalandresearchstudieswhichrequire a highlevel of knowledge,coordination,anddata abstraction.
Maintain regulatory binders/spreadsheetsforassignedprotocols.Prepare and submit annualrenewalrequests, amendmentsandadverse eventreportswithclinical input according to IRBand Sponsor requirements.Adhere to allprotocolrequirements to ensure the validity of the clinicalresearch data.
Assist the principalinvestigator andgrant/programmanager in defining informationandplansrequired to accomplishgoals of studies.Design and create protocol specific casereportformsasneeded.
Verify patienteligibilityfor studiesbycomparingpatient history andclinical laboratory results withprotocolrequirements.
Collect,enter andcompile clinicaldatafrom a variety of sources. Ensure accuracy andtimeliness of data so thatinformation may be usedby the physicians in treatment planning for individualpatients,andby the PrincipalInvestigator in grantwritings,presentations and publication.
Compile materialswhichaidphysicians/other staff in complyingwithprotocolrequirements.
Participate in all mandatory meetings to develop increasing knowledge of assignedresearchandclinicaltrials.
Developandmaintain a protocoldatabase or spreadsheetfor tracking patient activity,datacollection,andfinancialmanagement.
Preparefor and participate in monitoringand audits of studies. Write responses to auditreportswith input from the PrincipalInvestigator.
Complete minimum requirementfor continuing educational units. Isknowledgeable of andcomplieswithGoodClinicalPractices,ICH GuidelinesandDepartmentalResearchOfficepolicies. May instruct introductory levelresearchpersonnel in theseguidelinesandpolicies.
Prepare and submit invoices to sponsors in a timely manner.
Performallother duties as assigned.
This description is a general statement of required duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Minimum Qualifications (Mandatory):
High School Diploma/GED.
Two year’s related experience.
Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula.*
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Bachelor’s Degree required or equivalent.
Experiencewithworkingand interacting withpatients of at least one year.
Special Knowledge, Skills & Abilities:
Proficiency in the use of commonsoftwareapplications,databases,spreadsheets,andword processing required.
Excellent organizational skills required.
Excellentattention to detail skills required.
Must have ability to manage multiple andcompetingpriorities.
Must have excellent time management skills.
Must have excellentoralandwrittencommunication skills.
Must be able to workindependently.
The successfulapplicantwilldemonstrate an ability to workwellwithother professionalswithminimalsupervision,and be comfortable being part of a diverse professionalteam.
Classified Title: Research Program Assistant II
Starting Salary Range: $15.00 - $20.00/hr (commensurate with experience)
Employee group: Full Time
Schedule: M-F; 9am - 5pm
Exempt Status: Non-Exempt
Location: School of Medicine Campus
Department name: SOM DOM Hematology
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 email@example.com . For TTY users, call via Maryland Relay or dial 711.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. 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. 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/ .
The following additional provisions may apply, depending on campus. 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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Equal Opportunity Employer:
Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.
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