Sr. Research Program Coordinator
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- May 7, 2021
View more
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
Under direct supervision of the Director of the Pancreatic Cancer Center of Excellence at the Johns Hopkins University School of Medicine, the Sr. Research Program Coordinator is responsible for coordinating IRB submissions, protocol implementation, monitoring to ensure the collection of data for studies, and development and management of the Clinical, Genomic, Biospeciman databases. This is an intermediate level position in managing clinical trials and/or registry databases within the research program
Specific Duties and 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 supervise 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. Develop and manage the Clinical, Genomic, Biospeciman
databases.
-
Conduct the supervised researches on the Clinical,
Genomic, Biospeciman databases and participate in the preparing the
presentation and manuscript.
-
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.
-
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.
-
BA/BS required in Biological/Social Sciences,
Biostatistics, Public Health or other appropriate discipline
required.
Graduate level course
work or certification as a Clinical Research Professional and/or in
Biostatistics is preferred.
-
Requires a minimum of three years of related
experience required.
Minimum two 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 graduate level courses may
substitute for some work experience. Additional education may substitute for some
experience, to the extent permitted by the JHU equivalency
formula.
-
Excellent organizational skills
required
Excellent attention to detail skills
required
Knowledge of medical terminology
required
Familiar with database
management
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 the use of good
judgment, tact and sensitivity.
Classified Title:Sr. Research Program
Coordinator
Working Title: Sr. Research
Program Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range:$38,920 - $53,520;
commensurate with experience
Employee group: Full Time
Schedule: M-F 8:30am- 5:00pm
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10002940-Cancer Immunology/GI Clinical
Research
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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