Research Assistant
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Sep 13, 2021
View more
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
-
Will be involved in the research program including clinical trials
in compliance with institutional and federal
regulations.
Get involved with the start-up phase through to the completion
phase of the clinical trial.
Will be involved in regulatory application, protocol
implementation, compliance, recruitment, retention, and final
completion of the trial.
Complies with all regulatory/IRB guidelines including, but not
limited to: preparation and submission of study protocols, consent
forms, amendments, and annual continuing
reviews.
As such, will collaborate in development, preparation, and
maintenance of regulatory documents; collaborate in determination
of roles and responsibilities of study team members in the
implementation of assigned clinical trials.
Collaborate in the development of study tools including data
collection forms, eligibility checklists, and pre-printed
orders.
Follow all institutional research rules and
guidelines.
Represent study team at study initiation
meetings.
Assist with organizing case report forms and regulatory
binders.
Screen potential research subjects for participation in clinical
trials; evaluate ongoing eligibility of research subjects’
participation in clinical trials.
Demonstrate an understanding of the informed consent
process.
Obtain informed consent from research subjectsas
perprotocol and document obtaining of informed consent in
the medical record.
In conjunction with PI, monitor protocol enrollment goals and
collaborate in the development of recruitment strategies to ensure
accrual and retention within goal time frames; demonstrate
knowledge of protocol endpoint definitions.
Assist with ensuring collection of pertinent data from internal and
external sources. Monitor compliance with requirements of assigned
clinical trials.
Maintain Data sources consistent with GCP guidelines and respective
protocols.
Obtain and ensure proper distribution of required pharmacokinetic
& tissue samples.
Schedule, perform, and/or monitor procedures and tests per protocol
requirements.
Ensure and coordinate correct documentation of clinical study in
medical record and appropriate protocol documents. Schedule visits,
tests and procedures for patients entered in clinical trials per
the protocol.
As appropriate, ensure all required signatures are obtained on
informed consent documents and validity of available informed
consent documents.
Perform subject interviews and assessments at study visits for data
collection required by protocol, as appropriate.
Apply pharmacologic knowledge to assist PI in determining adverse
event causality and relationship to study drug/procedure. As
appropriate, performs phlebotomy per policy and procedures; and
documents per institutional standards.
Make return (~monthly) participant visits and coordination as well
as, blood draws in addition to clinical
assessments.
High degree of understanding of research and applies general
analytical skills to administer the logistical implementation of
assigned projects, and to identify situations requiring special
attention. Utilizing this knowledge, will ensure adherence to
research protocols, operating procedures, and all associated
internal/external regulations.
Using working knowledge will assist in developing recruitment tools
for assigned study(s), which include protocol/study specific data
collection forms, drafting and placing approved advertisements, and
contacting physicians for possible referrals.
Develop moderately complex tracking database/spreadsheet based on
study requirements utilizing Excel, REDCap, or similar software
applications.
Abstract data from patient medical records that requires some
interpretation. Monitors data quality and accuracy as required by
research protocol. Will run pre-established queries and may develop
ad-hoc queries/reports as requested.
Utilizing working knowledge of study(s) will participate in
meetings to provide operational updates, report on any operational
issues, and may make recommendations for resolutions to
new/outstanding operational issues. Will coordinate study(s)
meetings, including developing an agenda and coordinating
information and participation of individuals from other
institutions.
Oversee budget expenditures based on the study(s) operational
expectation.
Will act as the primary contact for study participants, including
scheduling, confirming appointments, and escorting/directing to
various locations on/off campus.
Ensure that case files and accompanying paperwork are organized and
current.
Assists with data analysis, interpretation, manuscript and abstract
preparation. Although training in statistical analysis is not a
requirement, familiarity with data analysis software is a
plus.
Opportunity for participation in scholarly activity and paper
authorship.
-
Bachelor’s Degree in a related field is required. Master’s Degree
in a related field is helpful but not required.
Some related experience. One (1) year of clinical, patient-oriented
research experience preferred.
Additional related experience may substitute for required
education, to the extent permitted by the JHU equivalency
formula.
Must maintain currentrequiredresearch certifications
during duration of employment.
Completion of the JHH required training prior to start
date.
Ability to demonstrate knowledge and skills necessary to perform
her role as it pertains to women reproductive health
research.
Able to prioritize workload and manage multiple projects
effectively.
Must achieve and maintain a working knowledge of computer software
specific to department, including Microsoft Word and Excel, e-mail
and internet functions and is knowledgeable of the Johns Hopkins
Institutional Review Board and departmental Standard Operating
Procedures.
Classified Title: Research
Assistant
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $16.42 - $22.57/hr (commensurate with
experience)
Employee group: Full Time
Schedule: Monday - Friday, 8:30 am - 5:00 pm
Exempt Status: Non-Exempt
Location: School of Medicine Campus
Department name:
Reproductive Science and Women's Health
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 atjhurecruitment@jhu.edu. 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 or because the individual is pregnant or attempting to become pregnant. 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 which campus you will work. 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.
Equal Opportunity
Employer
Note: Job Postings are updated daily and remain online until
filled.
EEO is the
Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf
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
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