JOB TITLE: Clinical Research CoordinatorDEPARTMENT: Clinical ResearchREPORTS TO: Clinical Research ManagerPRIMARY OBJECTIVE: Assists with the coordination of all aspects of conducting clinical trials/studies including enlisting study subjects, documentation, compliance and regulatory reporting, and liaison activities between the patients, investigators, primary care providers, sponsors and the Institutional Review Board (IRB). Maintains an in-depth knowledge of protocol requirements and good clinical practices (GCP) set forth by federal regulations.RESPONSIBILITIES:
Assists with the review of new studies and discusses with the department manager and physicians to determine feasibility.
Recruits, screens, enrolls and follows study subjects ensuring protocol compliance and close monitoring while the subjects are on study.
Communicates with sponsors, contract research organizations (CRO's), staff, and investigators regarding the conduct of studies.
Completes Institutional Review Board (IRB) applications, quarterly and annual progress and compliance reports.
Maintenance of accurate and complete documentation, including but not limited to regulatory documents, signed informed consent forms (ICF), relevant IRB correspondence, source documentation, drug accountability records, and subject related communications.
Participates in all aspects of clinical trials/studies including, but not limited to, timeliness in completing CRF's, data entry, reporting adverse events (AE), and preparing the necessary documentation for study close out.
Communication of all protocol related issues to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial, concerns regarding possible AE's or subject compliance. Provide general updates on a regular basis.
Participates in site audits by the sponsor, CRO, IRB or the FDA as required.
Performs administrative functions including word processing, filing, faxing, scheduling, and documenting submissions.
Collects data for research studies and enters it into databases using Microsoft Access and Excel.
Provides assistance with financial oversight of trials/studies including reviewing budgets and tracking payments. Reports financial status to the Clinical Research Manager.
ESSENTIAL SKILLS AND ABILITIES TO EFFECTIVELY PERFORM RESPONSIBILITIES:
Maintains a high level of confidentiality.
Exercises sound conduct of the clinical trial/study including, but not limited to, recruitment, screening, enrollment, and follow up of eligible subjects according to protocol requirements (e.g. subject follow up, case report form completion, and reporting adverse drug/device experiences).
Professional conduct in the presence of physicians, subjects, other research staff, sponsors, the IRB, outside vendors and customers, and other clinic staff.
Incorporates the use of technology into day-to-day tasks by using Outlook, Microsoft Office Suite, NextGen and UroChart effectively and accurately.
Experienced healthcare professional with a good understanding of the clinical research process and in-depth knowledge of protocol requirements and good clinical practices.
Minimum three years clinical research experience.
Associates or Bachelors Degree preferred.
CRC certification required.
Ability to work efficiently and independently in a high volume and fast-paced environment.
Ability to balance multiple projects with critical attention to detail.
Knowledge of NextGen Medical Practice Management System or other EMR system preferred.
A solid understanding of the Microsoft Office Suite.
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