Facilitates, maintains, and coordinates the logistical aspects of assigned study protocols with other research staff in accordance with Good Clinical Practice, standard operating procedures and sponsor requirements. Provides direct patient care pursuant to a study protocol including dispensation of investigational medications and performance of study tests under the delegation and direction of the principal investigator or supervising physician. Attends investigator's meetings, coordinates and attends pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required. Arranges for procedures and necessary visits performed by external vendors that are necessary to the conduct of the study. Schedules and leads in-house protocol meetings to review study-related procedures, staffing and visit flow. Schedules and coordinates all medical needs and coverage for protocol related procedures. Maintains and documents all study-related communication including, but not limited to the principal investigator or supervising physician, study subjects, Sponsor or Sponsor representative(s) and IRB throughout the clinical trial.
Responsible for giving subject instructions for study participation and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events. Ensures all protocol procedures are completed per study requirements. Obtains and documents all adverse event data on appropriate forms and reports adverse event data to the appropriate parties as outlined by the study protocol, regulations and applicable policies and procedures. Assures quality and completeness of source documents collected during the course of the study to assist with overall principal investigator review and approval. Ensures accurate, complete and timely data entry into CRFs using 100% source documentation verification to assist with overall principal investigator review and approval. Schedules, leads and assists with all study-related visits on site and is readily available during visits for applicable corrections, questions, or other study-related or site needs. Supervises document retention, security and destruction, where applicable. Responsible for completing all necessary training for the position, including study protocol specific training and Health System policies and procedures. Trains other study specific research staff in collection and reporting of required data, where applicable. Maintains research files, designs forms as needed, reports findings as appropriate, assists in preparation or review of material for submission to an IRB including reviewing and editing protocols and consent documents, where applicable. Performs all other functions as related to this job and assigned. Ability to travel between hospital locations where research is conducted. EOE Minorities/Women/Disabled/Veterans. VEVRAA Federal Contractor.
Bachelors Degree in related field.
Two years experience in managing all aspects of clinical research trials with in-depth knowledge of protocol requirements and Good Clinical Practice.
Intermediate computer and internet knowledge.
Excellent customer service and patient care skills.
Meticulous organizational skills.
Excellent demonstrated written and verbal communication abilities.
Three to Five years experience in clinical research trials.
ACRP or SOCRA certification.
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