Sr. Research Program Coordinator
Salary: $37,040 - $50,932
School: School of Medicine
Location: School of Medicine Campus
Resume Required for Application: Yes
Area of Interest: Research / Lab
Contact: Human Resources 410-955-2990
Department: Oncology - GI Cancer This position will be responsible for the data management of project data for the National Familial Pancreatic Tumor Registry and the Johns Hopkins SPORE in Gastrointestinal Cancer.
Maintain and update study data as needed using Progeny, REDCap or Stata
Perform quality assurance on data
Produce descriptive reports, including tables and graphs
Create research databases as needed, merging data, defining new variables
Work with external and internal investigators to create datasets needed for analytic projects
Work collaboratively with investigators, analysts and study coordinators
Update existing research databases to include new variables and changes to existing data fields
Write code to perform basic statistical and epidemiological analysis for research questions, manuscripts and contract/grant submissions
Consent and enroll patients into studies.
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.
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.
May assist clinicians/clinical research coordinators with patient screening, recruitment, and consenting. May perform interviews, complete structured tests, and collect pertinent data with potential/active research participants in the clinic.
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.
Weekly Schedule/Hours: Monday-Friday/8:30-5:00pm/37.5 hours
The position will be responsible for data management for a registry of pancreatic cancer families as well as projects within the Johns Hopkins SPORE in Gastrointestinal Cancer. In addition, to data management this position will also assist with submission of IRB and NIH protocols
Duties and Responsibilities:
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.
• 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.
Bachelor's degree in related discipline. Three years related experience. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Special Knowledge, Skills, or Abilities / Competencies:
• Proficiency with STATA, R or SAS is strongly desired.
• 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 trial financial contract
• Must have excellent time management skills
• Must have excellent oral and written communication skills
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.
Proficiency with STATA, R or SAS is strongly desired.
Certification as a Clinical Research Professional.
NOTE: 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 School of Medicine HR Divisional Office at 410-955-2990. For TTY users, call via Maryland Relay or dial 711.
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.