Sr. Research Program Coordinator II
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Jul 26, 2021
View more
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
-
Consent and enroll
patients into investigator-initiated and multi-site
studies.
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.
Coordinate patient visits,
collection of data, record maintenance, and regulatory
documentation. Responsible for the collection and accuracy of data
during each patient visit. Adheres to all protocol requirements to
ensure the validity of clinical research subject data. Determine
and report any abnormal symptoms of patient, including abnormal
readings during procedures.
Responsible for the
organization, entry, maintenance, and accuracy of all patient
clinical research data for complex and detailed studies. Maintains
a research chart for each patient. Collects, enters and compiles
clinical data from a variety of sources. Ensures accuracy and
timeliness of data so that information may be used by the physician
in treatment planning, presentations, and
publication.
Perform the following
procedures for studies: collect and process samples (e.g., blood,
urine, and tissue) and coordinate any procedures (i.e. x-rays,
etc.) and others per protocols.
Work with the research
pharmacy with coordinating the dispensing of investigational drugs
(if required).
Maintains regulatory
binder for each assigned protocol. Prepares and submits annual
renewal requests, amendments, adverse event reports, etc.,
according to IRB and other institutional and sponsor
requirements.
May assist the principal
investigator and/or program manager in defining information and
plans required to accomplish goals of studies, including design of
standard operating procedures. Will design and create protocol‑
specific case report forms as needed. May also assist less
experienced staff in design and creation of such
forms.
Meets regularly with study
team 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
research account/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/or external agencies. Enters patient demographic
and clinical data into institutional databases, as required.
Responds in a timely manner to special projects or queries related
to the data.
Prepares for and
participates in monitoring and audits of studies. Attend site
visits throughout the course of the study with pharmaceutical
representatives. On occasion, will prepare for and attend internal,
sponsor, FDA, OSHA, OHRP or JCAHO
inspections/audits.
Assist in writing
abstracts and manuscripts for different studies.
Completes minimum
requirement for continuing educational units. Is knowledgeable of
and complies with Good Clinical Practices, ICH Guidelines and SKCCC
Clinical Research Office policies.
Minimum Qualifications (Mandatory):
- BA/BS degree in Biological/Social Sciences or other appropriate discipline required. Additional graduate level course work is preferred.
- Minimum of 5 years’ experience in complex and detailed clinical trials/medical research is required.
- Minimum of 2 years’ experience in clinical trial and or clinical research in a patient setting required.
- Knowledge of research methodology and working knowledge of computers required.
- Knowledge of clinical research practices and principles required.
- Highly effective verbal and written communication skills, and highly developed interpersonal skills required.
- Must be able to independently assimilate and evaluate clinical data.
- Proficiency in Microsoft Office, especially Excel and Word, and a working knowledge of Access or other relational database is required.
- Must be familiar with medical terminology. Must be experienced in handling multiple tasks at once, and working well as a member of a team.
- Must have working knowledge of FDA reporting requirements.
- Additional education (graduate level) may substitute for required experience and additional experience may substitute for required education to the extent permitted by the JHU Equivalency Formula.
Licensure, Certification, Registration:
- Certification as a Clinical Research Professional is preferred.
Special Knowledge, Skills, or 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
General computer skills,
with experience with Microsoft Office
-
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 the use of good judgment, tact and
sensitivity.
This description is a
general statement of required major duties and responsibilities
performed on a regular and consistent basis by the
incumbent(s).
It should not be held to
exclude other duties not mentioned that are similar in nature and
level of difficulty.
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 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.
Classified Title: Sr.
Research Program Coordinator II
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $45,650 - $62,850 annually (commensurate
with experience)
Employee group: Full Time
Schedule: M-F 8am- 4pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name:
SOM Onc Hematologic Malignancies
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
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