ARJR Research Coordinator will be an integral member of the research team in compliance with all regulatory, institutional, and departmental requirements; participate in all aspects of research management and quality assurance of data for a specific project(s) as assigned. He/she will oversee the day-to-day activities of Collaborative Orthopaedic Replacement Registry (CORRe) reporting to the Adult Reconstruction and Joint Replacement (ARJR) Manager of Clinical Research. Responsible for data management activities associated with clinical research at a departmental specific level; perform data collection, data entry and analysis for studies as appropriate.
The successful applicant for the position of Clinical Research Coordinator will be a highly motivated and organized individual who is able to perform a variety of different tasks essential to the implementation of a clinical study. He or she should be comfortable handling various technical aspects of databases and should be able to analyze data. The applicant must be able to multitask and prioritize research projects. The Coordinator will have access to the medical records of patients, and should appreciate this privilege, and maintain strict confidentiality with all patient medical data. A qualified candidate will have the ability to communicate in an effective manner with management, clinical staff, external sponsors and patients at HSS. The candidate will also have good interpersonal skills, as he or she will interface directly with patients and medical staff on a routine basis. He or she will be flexible, as the job description may evolve as studies progress. The applicant must be available on site at the main hospital.
DUTIES AND RESPONSIBILITIES:
Leading Development of Analytic Infrastructure
- Performs advanced data queries. Provides regular and timely reports to Institutional Review Board, Principal Investigator, ARJR Service Co-Investigators and scientists
- Performs quality assurance audits on the registry. Ensures accuracy of personnel transcribing data from paper case report form (CRF) into an electronic format.
- Compiles and assists in analyzing and interpreting data in preparation for a presentation, sponsor/regulatory agency, publication, etc… with the assistance of project investigator
Clinical and Regulatory responsibilities:
- Oversees and conducts the informed consent process on studies as appropriate (requires appropriate training and certification of human research subjects training).
- Manages data collection specific to research studies including but not limited to the performance of measurements for applicable studies, collection of clinical data from patients directly, and manage the performance of all other duties as put forth in the protocol. This includes the supervision of multidisciplinary teams involved in the successful conduct of the study as well as research assistants I and II assigned to independent research studies.
- Manages and executes IRB submissions for initial approvals, re-approvals, amendments, etc… Ensures timeliness and accuracy of submissions and no lapses in approvals for the study. May also direct research assistants in this effort during Manager’s absence.
- Collaborates with the research team, departmental research manager, and research administration, as needed, to ensure that research subjects are treated in accordance with all mandated requirements. Ensures that standards regarding subject registration, protocol specific tests, and required documentation are adhered to. Reports deviations as appropriate and resolves issues when possible. Escalates issues to supervisor as needed.
Administrative and Other Duties:
Represents the Principal Investigator in departmental audits as well as external audits performed by representatives of the sponsor for each clinical research project. Works closely with HSS internal monitor for guidance on these activities.
- Assists ARJR Manager with review of protocols and creating budgets for clinical trials when needed.
- Participates in cross-functional process initiatives
- Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management.
- Bachelor’s degree minimum/Master’s preferred
- Certified Clinical Research Coordinator (CCRC) preferred
- 3-5years (Education may substitute for 2 years of experience)
- Knowledge of Good Clinical Practice and Good Technology Practice
- Proficient use of computers and software
- Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus
- Experience in IND filings, NDAs and 510(k) filings is a plus
- Computer literacy: MS Word, Excel, Powerpoint, RedCap, Epic, EDC Statistical software such as R, SAS, SPSS or STATA