Sr. Research Program Coordinator
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Posted
- Feb 19, 2021
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
-
Maintains an excellent
working knowledge of all assigned protocols and reporting
requirements.
Works on complex clinical
studies, which require a high level of expertise, coordination, and
data abstraction.
Transmits and distributes
protocol information.
Responsible for
submission, verification, and maintenance of protocol-specific
information on the SKCCC Research Protocol
Library.
Maintains regulatory
binder for each assigned protocol.
Prepares and submits
annual renewal requests, amendments, and adverse event reports with
clinical input according to IRB and Sponsor
requirements.
Adheres to all protocol
requirements to ensure the validity of the clinical research
data.
May assist the principal
investigator and program manager in defining information and plans
required to accomplish studies' goals.
Will design and create
protocol‑ specific case report forms as needed.
May also assist less
experienced staff in the design and creation of such
documents.
Verifies patient
eligibility for studies by comparing patient history and clinical
laboratory results with protocol requirements.
Confirms patient
registrations and relevant data points in databases for the SKCCC
Clinical Research Office and Oncology Information
Systems.
Maintains a research
chart for each patient.
Collects, enters, and
compiles clinical data from a variety of
sources.
Ensures accuracy and
timeliness of data information for the physician in treatment
planning, presentations, and publications.
Verifies scheduling of
patient appointments, tests, and follow-up visits at the
appropriate time in the treatment cycle to ensure completion of
protocol requirements.
May design and compile
materials which aid physicians/other staff in complying with
protocol requirements for these visits and
tests.
Meets regularly with
Principal Investigator, Research Nurse, and Research Program
Manager to review data accuracy and overall study
progress.
Participates in all
mandatory meetings to develop increasing knowledge of assigned
clinical trial and Registry requirements.
Will develop and maintain
a protocol database or spreadsheet for tracking patient activity,
financial management, and data analysis as
needed.
Will meet with clinical
trial financial management staff to identify procedures, laboratory
tests, and protocol events that require invoicing to the Sponsor as
defined in the financial contract.
May participate in the
development of invoicing schedules.
Prepares reports on
individual patients or the study as required by the principal
investigators and external agencies.
Enters patient
demographic and clinical data into the institutional database as
needed.
Timely response to
particular projects or queries related to the
data.
Prepares for and
participates in monitoring and audits of
studies.
Corrects errors in the
database when necessary.
Writes responses to audit
reports with input from the Principal
Investigator.
Completes minimum
requirements for continuing education units.
Knowledgeable of and
complies with Good Clinical Practices, ICH Guidelines, and SKCCC
Clinical Research Office policies.
May instruct
introductory-level clinical research personnel in these guidelines
and procedures.
-
BA/BS
degree in Biological/Social Sciences or other appropriate
discipline required.
Minimum
three years of experience in complex and detailed clinical
trials/medical research required.
Proficiency in the use of software applications, databases,
spreadsheets, and word processing
required.
Additional
education may substitute for required experience, to the extent
permitted by the JHU equivalency
formula.
Special Knowledge, Skills, and Abilities:
-
Excellent
organizational skills
required
Excellent
attention to detail skills
required
Knowledge
of medical terminology
required
Familiar
with medical procedure and laboratory
fees
Ability to
manage multiple and competing
priorities
Knowledge
of clinical research practices and principles
required
Ability to
understand a clinical trail financial
contract
Must have
excellent time management
skills
Must have
excellent oral and written communication
skills
-
Must
adhere to guidelines regarding honest reporting of sensitive and
confidential patient
information.
Understands the importance/impact of data integrity in terms of
patients, study results, costs, quality of service, and scientific
research in general.
Regular
contact with physicians, other health care personnel, and
occasionally, patients requires good judgment, tact, and
sensitivity.
Classified Title:Sr. Research Program
Coordinator
Working Title: Sr. Research Program
Coordinator
Role/Level/Range: ACRP/04/MB
Starting Salary Range:$38,920-$53,520 (commensurate
with experience)
Employee group: Full Time
Schedule: Monday-Friday/8:30am-5:00pm
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10002938-SOM Onc Upper Aerodigestive Cancer
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.
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://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