Sr. Research Program Coordinator
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Sep 23, 2021
View more
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
Specific Duties & Responsibilities:
-
Maintains good working knowledge of all assigned
protocols and reporting requirements. Works on complex clinical
studies which require a high level of knowledge, 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/or program
manager in defining information and plans required to accomplish
goals of studies. Will design and create protocol‑ specific case
report forms as needed. May also assist less experienced staff in
design and creation of such forms.
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 so that
information may be used by the physician in treatment planning,
presentations, and publication.
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/or external
agencies. Enters patient demographic and clinical data into
institutional database 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. Corrects errors in database when necessary.
Writes responses to audit reports with input from the Principal
Investigator.
Completes minimum requirement for continuing
educational units. Is 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
policies.
Minimum Qualifications (Mandatory):
- BA/BS degree in Biological/Social Sciences or other appropriate discipline required. Additional graduate level course work is preferred.
-
Minimum three years’ experience in complex and
detailed clinical trials/medical research
required.
Proficiency in the use of software pplications,
databases, spreadsheets, and word processing
required.
- 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.
Classified Title: Sr.
Research Program Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $39,310 - $54,060 annually (commensurate
with experience)
Employee group: Full Time
Schedule: M-F 8:00am- 4:00pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name:
SOM Onc Pediatric Oncology
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 jhurecruitment@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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