EVMS
Location
Norfolk, VA | United States
Job description
To oversee several research studies and perform all aspects of patient contact related to that study (i.e., recruiting, scheduling, performing all patient tests and completing all documentation as outlined by the protocol and required by the Internal Medicine Research Center SOP’s). Assist with performing various patient tests as needed, including phlebotomy and vital signs, processing and shipping of specimens which can be provided through on-the-job-training. To work with the clinical research team on various other clinical study protocols as needed, including recruitment and study data collection.
Maintain regulatory documents in an organized manner;
Assist with planning and preparing for all details necessary for smooth operation of a study prior to study initiation;
Evaluate potential study volunteers on an individual basis and obtains in depth medical history as related to study inclusion/exclusion criteria to assist the investigator in the eligibility evaluations for enrollment of a potential patient;
Screen and recruit patients through chart reviews, phone calls, attendance at lectures, health fairs, etc., as well as to coordinate the recruitment efforts of other clinical research staff;
Schedule patients for all study visits according to the schedule required by the study protocol;
Review study protocols, informed consent forms, and follow-up procedures with potential study patients;
Assist with performing various patient tests as needed, including phlebotomy and vital signs, processing and shipping of specimens which can be provided through on-the-job-training;
Ensure appropriate specimen collection as indicated by study protocol;
Review laboratory data and communicate abnormal values to the principal investigator and the primary care provider;
Transcribe study data from charts onto the case report forms, if required;
Collect and document all data required by the study protocols and maintain the subject binders in an organized manner;
Assess and document subject compliance with medications and visits;
Administer study drug therapy as needed and maintain the study drug-dispensing log (as legally appropriate);
Maintain communication with the sponsoring companies/sponsors, including reporting of any serious adverse events;
Obtain and submit regulatory documents as required by sponsor. Arrange for visits from monitors, provide them with access to study files and work with them on any changes or corrections to case report forms;
Coordinate the activities of various research team members to ensure completion of study objectives;
Responsible for notifying proper personnel when required supplies are needed;
Perform database entry and assist with data in electronic data capture (EDC) systems;
Performs other duties as assigned.
Bachelor’s degree from a four-year college or university. Relevant experience is preferred.
US-VA-Norfolk
Job tags
Salary
