The Department of Oncology seeks a Clinical Research Annotation Specialist (Sr. ResearchProgram Coordinator) who will work under limited supervision of the Clinical Research Program Manager and will be responsible for abstraction of key clinical data from medical records and investigational laboratory research to unify data between study teams to facilitate collaboration across the Urologic Oncology program. This requires a high level of clinical knowledge, understanding of advanced medical terminology and disease states, and organization. Responsibilities will include collaborating directly with investigators, research fellows and staff to identify research objectives, as well as assist research teams at different stages of protocol development, data analysis, publication, as well as assist with general operations of the program. Experience with REDCap database is preferred.
Specific Duties & Responsibilities:
Work closely with Clinical Research Program Manager and PI's to explore new concepts, and annotate data from multiple research teams to facilitate collaboration, with special focus on genomic profile, treatment choice, and disease progression.
Develop and maintain REDCap database to capture clinical annotation data.
Lead and coordinate clinical research protocol development, abstracts and manuscripts preparation with PI(s) and co-investigator(s).
Facilitate clinical trial referral based on chart review and clinical annotation data analysis.
Collaborate with Multicenter Clinical Trial Specialists in conducting investigator-initiated multicenter protocols, including patient eligibility review, data monitoring, safety review, and other protocol-related tasks to facilitate data analysis and reporting.
Maintain a continued high level of expertise in institutional databases including Epic, CRMS, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
Participate as requested in Cancer Center events such as training and orientation for new research staff, new database testing, and contributing to new initiatives.
Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies.
Ensure that Cancer Center policies, SOPs, and guidelines related to the conduct of clinical trials are followed.
Minimum Qualifications (Mandatory):
BA/BS degree in Biological/Social Sciences or other appropriate discipline required.Master's preferred.
Minimum of 5 years' experience in complex and detailed clinical trials/medical research is required with at least 2 years experience in a patient setting.
Working knowledge of RedCap or other relational database is highly preferred.
Additional education may substitute for required experience to the extent permitted by the JHU Equivalency Formula.
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.
Licensure, Certification, Registration:
Certification as a Clinical Research Professional is preferred.
Special Knowledge, Skills, or Abilities:
Highly effective verbal and written communication skills, and highly developed interpersonal skills required.
Must be able to independently assimilate and evaluate clinical and research data.
Proficiency in Microsoft Office, especially Excel and Word.
Knowledge of research methodology required.
Knowledge of clinical research practices and principles required.
Knowledge of medical terminology required.
Excellent organizational and time management skills required.
Excellent attention to detail skills required.
Equipment, Machine, or Tool Requirements:
General computer skills, with experience with Microsoft Office.
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 the 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 Working Title: Clinical Research Annotation Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $45,650 - $62,850 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30am- 5:00pm Exempt Status: Exempt Location: School of Medicine Campus (Hybrid Schedule) Department name: SOM Onc Urologic Oncology Personnel area: School of Medicine
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