Location: Baltimore, Maryland
Internal Number: 107771-en_US
Under the direct supervision of the Sr. Clinical Research Program Manager and the Principal Investigator(s), we are seeking a Research Program Coordinator who will be responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols in the Developmental Therapeutics Program. The Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. This is an introductory level position in managing clinical trials and/or registry databases.
Specific Duties & Responsibilities
- Manages and coordinates patients on trials which can include ordering, scheduling, patient interactions/assessments, and data input. Utilizing the study calendar, tracks patient progress and upcoming visits for accuracy. May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
- May assist with consenting study participants and documenting the consent process. Documents telephone and other communications with patients per institutional policy.
- 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.
- When necessary, requests pertinent patient records and tissue samples as required.
- 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 for individual patients, presentations and publication.
- Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Responds in a timely manner to special projects or queries related to the data.
- Maintains a protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries.
- Maintains a research chart for each patient.
- Maintains good working knowledge of all assigned protocols and reporting requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data.
- Disseminates protocol information and updates to other study team members, as necessary.
- Prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements.
- Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library, and the Clinical Research Management System.
- Maintains regulatory binder for each assigned protocol.
- Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary.
- Meets regularly with members of the 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.
- May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. May help design and create protocol specific data collection forms with assistance.
- Completes minimum requirement for continuing educational units. Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.
- Bachelor's Degree in related discipline.
- Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
- Experience working with patients and/or in a clinical setting preferred.
- Proficiency in PC operations and software applications such as MS Windows, Excel, Word, and Adobe/Foxit.
- Ability to learn new database and software applications is required.
- Excellent organizational skills required.
- Excellent attention to detail skills required.
- Ability to manage multiple and competing priorities.
- Must have excellent time management skills.
- Must have excellent oral and written communication skills.
Classified Title: Research Program Coordinator
Starting Salary Range: $16.75-$23.00-$29.30 HRLY (Commensurate with experience)
Employee group: Full Time
Schedule: M-F, 830-500
Exempt Status: Non-Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Onc Developmental Therapeutics
Personnel area: School of Medicine
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
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