HSS Florida is looking for a Clinical Research Coordinator who 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. ensuring efficient operations. The Research Coordinator will be responsible for establishing research infrastructure and overseeing research for HSS Florida. Responsible for data management activities associated with clinical research and performs data collection, data entry and assists with manuscript writing.
DUTIES AND RESPONSIBILITIES:
Clinical and Regulatory responsibilities:
Establish research infrastructure for HSS Florida and oversee research
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 registry and 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.
Spearheads efforts to meet patient enrollment targets related to independent research studies. To that end, develops and implements various recruitment strategies.
Ensures accuracy of personnel transcribing data from paper case report form (CRF) into an electronic format.
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.
Compiles and assists in analyzing and interpreting data in preparation for a presentation, sponsor/regulatory agency, publication, etc… with the assistance of biostatistician and principal investigator
Performs advanced data queries when needed. Provides timely reports to Institutional Review Board, Principal Investigator, National Institutes of Health and/or sponsor for each research project.
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.
Conducts study specific team meetings to ensure timely progress of patient enrollment and study activities.
Collaborates with the research team, departmental research director, 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.
Responsible for the handling, packaging, and shipping of dangerous goods under supervision and in compliance with State and Federal regulations. These specimens may include tissue, blood, dry ice, and chemicals. Certification in these procedures is required in accordance with the Federal Regulations. Knowledge of good clinical practice for the handling of specimens and blood will be required.
Assist Principal Investigator with writing/editing abstracts and manuscripts as needed.
Provide overall administrative support for clinical research activities and academic commitments including but not limited to: academic presentations, conferences, and editorial commitments.
Assists in patient care coordination by assuring patients complete patient reported outcomes prior to office visits.
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. Attends departmental grand rounds as well as internal training sessions.
The successful applicant for the position of 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 will be flexible, as the job description may evolve as studies progress. 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 Florida. The candidate will also have good interpersonal skills, as he or she will interface directly with patients and medical staff on a routine basis. The applicant must be available on site at the hospital during patient visits.
Bachelor’s degree minimum/Master’s preferred
Certified Clinical Research Coordinator (CCRC) preferred
Knowledge of Good Clinical Practice and Good Technology Practice
Experience in IND filings, NDAs and 510(k) filings is a plus
Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus
Computer literacy: MS Word, Excel, Powerpoint, RedCap, Epic, EDC