University of Pittsburgh Physicians is hiring a Full-Time Clinical Research Associate, Clinical Trials to help support the Anesthesia Clinical Trials Department for its Various locations. Position requires occasional evenings, weekends, and early starts, i.e. 5 a.m. start. Work with physicians, nurses, and other allied health professionals to facilitate clinical research trials and to collect timely and accurate data.
-Facilitate entry of patient on to clinical trials by performing the following tasks
-Assist in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor.
-Submit all required documents for contracting research studies.
-Revise, renew and maintain IRB approval, protocols and consent forms for studies.
-Involved with the identifying, recruiting , consenting process and study implementation of lab requisitions.
-Assist in verifying subject eligibility according to protocols by reviewing medical records, laboratory, and radiology results
-Insure that patient's records, tests, lab work results, etc. are obtained and reviewed prior to patient entry onto a study.
-Create study specific source documents, case report forms and study visit checklists.
-Meet with the principal investigator and Clinical Research Coordinator/Supervisor to review patient and/ or study status on as needed basis
-Complete research requisitions to assist billing department to prevent billing of research procedures to third party payers.
-Perform trial related responsibilities as required such as processing, storing and shipping trial specimens, conducting assessments, and administering study related questionnaires to study participants (i.e. quality of life, pain assessments, etc.).
-Monitor subject compliance of oral study medications.
-Responsible for prompt and accurate data collection for protocols
-B.A. degree in Business, Healthcare or related field, or
-LPN license and a minimum of 2 years of clinical research experience or
-High school graduate with current certification as a Clinical Research Associate from either the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) along with a minimum of three years of clinical research experience.
-Prior experience submitting contracts to University of Pittsburgh and OSPARS highly preferred.
Industry Sponsored Clinical Trial Research experience highly preferred.
-Demonstrated ability to effectively communicate with subject/patients, staff and investigators as to maintain patient confidentiality.
-Knowledge and use of MS office software products and the ability to work with PC database applications.
-Excellent organizational skills and be able to work on projects/tasks simultaneously.
-Highly motivated and be able to work with minimal supervision.
-Ability to interact with patients/study participants, research staff and medical staff.
-Ability to adapt to multiple organizational structures.
-Ability to meet deadlines and be flexible in response to sudden workload changes.
-IRB experience preferred
-Strong knowledge of medications, surgeries and medical terms highly preferred.
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