Job Description Effectively coordinates the conduct of clinical research studies under the direction of the Principal Investigator, Research Director, Clinical Research Supervisor and department leadership. Oversees recruitment of patients by screening patient eligibility of potential study participants with physicians, leading to consent and enrollment as appropriate. Performs protocol mandated activities such as specimen collection and processing, vital signs, administers questionnaires, collects diaries, and documents patient response to interventional therapies. Schedules and tracks protocol related testing and follow-up appointments. Documents and organizes protocol related activities consistent with protocol guidelines, institutional and departmental policies, Good Clinical Practice and Federal Regulations. Reports adverse and serious adverse events to the Principal Investigator, documenting and reporting to the appropriate agencies within the required timelines. Acts as a liaison with physicians, clinical staff, pharmacy, and study sponsors. Acts as a resource regarding protocol specific information. Coordinates the processing and maintenance of essential regulatory documents at an audit ready level as assigned. Performs other related duties as assigned.
Minimum Qualifications: 1. Degree in a Healthcare or related field preferred 2. One year of research coordinator work experience preferred. May be acceptable in lieu of education or a combination thereof 3. Minimum two years of experience in a related healthcare position (such as a Medical Assistant, Nursing Assistant) required 4. Clinical research experience preferred, certification preferred or willing to obtain 5. Familiar with principles of protocol development, study design and IRB process required 6. Proficient in word processing, spreadsheets and database management required 7. Travel as required 8. Willing and able to complete additional training (IATA, EMR, etc.) as required 9. BLS Required. Current AHA Healthcare provider, American Red Cross, AHA Health Saver or KH BLS during General Orientation.
Essential Job Functions: Regular and predictable attendance is an essential job function. · On feet a minimum of 8-12 hours, depending on length of shift. · Frequent stooping, bending, reaching, lifting and pushing. · Read charts, dials, equipment settings, literature and other printed and handwritten materials. · Communicate with patients, physicians, families and co-workers in person and on telephone. · Able to use sensory and cognitive functions to process and prioritize information, treatment, and follow-up. · Able to use fine motor skills. Able to record activities, document interventions. · Able to use computer and learn new software programs.
Work Environment: · Operational needs of departments may require that you be available to work on call, weekends and holidays to meet the needs of the studies and subjects. · Work is normally performed in a typical interior work environment.
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