Clinical Research Coordinator New! Heart Center Research | Full-Time | Phoenix ...Read More Qui[...]

Position Summary This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides administrative and regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements. Position Duties Ensures assigned studies are conducted in accordance with the FDA, OHRP, GCP, and institutional guidelines. Reviews all regulatory requirements to ensure appropriate methods, practices, and procedures for all research activities in designated area. Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis. Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors. With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants. Completes all tasks required by study sponsors. Provides regulatory documents to sponsor in a timely manner. Completes case report forms, data entry, and maintains source documentation for all study participants. Tracks and reports adverse events per sponsor and institutional guidelines. Coordinates research monitor visits and responds to all data queries. Coordinates the process for opening new studies. Obtains needed background material on proposed research projects; presents findings and information to principal investigator. Completes feasibility questionnaires. Circulates the confidentiality disclosure and trial agreements to the appropriate parties. Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial. Assists in development of workflow procedures for the study team based on specific protocol. Participates in recruitment and selection of study participants, coordinates research subject informed consent and entry into appropriate research studies ensuring inclusion and exclusion criteria are met. Coordinates and schedules a variety of medical procedures/tests such as laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac/pulmonary function tests as required by the study protocol. Provides study‑specific education to the participant and their family, covering procedures, diary or study log documentation, proper dosage/administration, and disease treatment. Reviews monthly financial reports, including study participant billing, expenditures, and revenue; maintains inventory levels of all supplies and equipment; initiates requisitions for replacement items; maintains equipment to provide continuous operational efficiency. Participates in professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area. Performs miscellaneous job‑related duties as requested. Position Qualifications Education Bachelor’s degree in related field or equivalent combination of education and experience. Experience One year of clinical research experience or equivalent clinical research training program approved by Director, Clinical Research Operations. Special Skills Proven ability to successfully coordinate multiple studies adhering to regulatory and institutional guidelines. Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care. Additional Requirements ACRP or SOCRA Clinical Research Certification (preferred). Clinical Research Training Certification (preferred). Phlebotomy Certification (preferred). Physical Requirements & Occupational Exposure/Risk Potential Physical Requirement – Feeling (sensing textures and temperatures) – occasionally. Physical Requirement – Fine Motor Skills (pinching, gripping, etc) – occasionally. Physical Requirement – Hearing – constantly. Physical Requirement – Pushing/pulling – occasionally. Physical Requirement – Reaching – occasionally. Physical Requirement – Sitting – frequently. Physical Requirement – Standing – occasionally. Physical Requirement – Stooping/crouching/kneeling/crawling – occasionally. Physical Requirement – Talking – frequently. Physical Requirement – Walking – frequently. Physical Requirement – Near Vision – frequently. Physical Requirement – Far Vision – frequently. Physical Requirement – Color Discrimination – frequently. Physical Requirement – Use of keyboard, mouse and/or computer equipment – frequently. Physical Requirement – Lift up to 35 pounds without assistance – occasionally. Occupational Exposure/Risk Potential – Inside office environment – applicable. Occupational Exposure/Risk Potential – Airborne communicable diseases – applicable. Occupational Exposure/Risk Potential – Bloodborne pathogens or bodily fluid – applicable. #J-18808-Ljbffr Phoenix Children's Hospital, Inc.