An advanced position that contributes to the overall operations of one or more research studies. The CRC is responsible for implementation of the study protocol, recruitment plan, study visits, data, study assessments, and other tasks outlined in the protocol. This position requires close collaboration with the study team and investigator to ensure safe and compliant research procedures and follow-up per the established research protocol. This position will work directly with research participants, physicians, nurses, community stakeholders, and health/social service organizations. This position has opportunities for ongoing learning and contribution to research that is focused on improving health and wellbeing of individuals and the community. Coordinates research studies per Good Clinical Practices guidelines, FDA regulations, and approved protocols. Understands and adheres to Standard Operating Procedures (SOPs). Ability to develop or improve SOPs, help guides, and other team resources. Acquires detailed knowledge of assigned research protocols and ability to conduct study required processes, procedures, and assessments. Ability to prepare, utilize, and review Case Report Forms. Collects and manages data, Case Report Forms, and timely entry into the electronic data capture system. Collects and assists with processing all laboratory specimens to include centrifuging, separating, measuring, storing, shipping, and distributing to appropriate testing areas. Maintains inventory of laboratory supplies and study kits. Screens, recruits, and enrolls study participants using study’s eligibility criteria. Performs the informed consent, answering all participant questions, and obtaining appropriate sign-off. Ensures the adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data. Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events. Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials. The individual must be able to work the hours specified. To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer. Required Education, License/Certification, or Work Experience: Bachelor's From a four year college or university within the health and science field. Preferred Education, License/Certification, or Work Experience: 1-3 years Human Research, 1-3 years Laboratory or clinical. Commitment to the daily application of Avera’s mission, vision, core values, and social principles to serve patients, their families, and our community. Promote Avera’s values of compassion, hospitality, and stewardship. Uphold Avera’s standards of Communication, Attitude, Responsiveness, and Engagement (CARE) with enthusiasm and sincerity. Maintain confidentiality. Work effectively in a team environment, coordinating work flow with other team members and ensuring a productive and efficient environment. Comply with safety principles, laws, regulations, and standards associated with, but not limited to, CMS, The Joint Commission, DHHS, and OSHA if applicable.
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