Job Description

Job Profile Summary This role focuses on research and development of new products, innovation, and process improvement. It involves supporting the development of new products, including clinical research roles. Positions in this family perform basic, translational, and/or clinical research to solve specific problems for an entity or community. It is a professional individual contributor role that may direct lower-level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation, or delivery of processes, programs, and policies using specialized knowledge and skills typically acquired through advanced education. It is an entry-level role that applies broad theoretical job knowledge typically obtained through advanced education and may require proficiency in supervised work, with problems that are not typically difficult or complex, and involves explaining facts, policies, and practices related to the job area. Job Overview This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. Job Description Minimum Qualifications Bachelor's degree OR High School Diploma or equivalent AND four (4) years of related experience. Basic Life Support (BLS) certification may be required based on specific role requirements. Preferred Qualifications Two (2) years in research-related activities. IATA Hazardous Goods Shipping certification. CITI Human Research Protection certification. Duties and Responsibilities The duties and responsibilities listed below are intended to describe the general nature of work and are not exhaustive. Other duties may be assigned. Assists in the recruitment of study participants. Completes follow-up with study participants in prescribed settings as required. Completes record abstraction of source documents, conducts required study measurements, and completes study Case Report Forms in accordance with best practice methods. Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors clinical adverse events, reporting any to the PI, study sponsor, and IRB. Assists with IRB requirements, including meeting educational requirements, submitting amendments, adverse event reports, and annual reviews. Performs basic laboratory activities as needed. Maintains patient confidentiality per HIPAA regulations and keeps study information secure. Adheres to FDA Good Clinical Practice Guidelines. Identifies and resolves protocol compliance problems by notifying the investigator and protocol sponsor. Arranges necessary tests and procedures according to protocol requirements and reports results to the investigator. Participates in site visits with the study sponsor to review documentation. Maintains inventory of all study supplies. Assesses potential patients for protocol inclusion based on eligibility criteria. Reviews all eligibility criteria in patient records and verifies information with the physician. Interviews patients to obtain eligibility information, explains the study, and obtains informed consent signatures. Conducts QC checks of completed CRFs prior to data entry. Coordinates resolution of data queries. Completes data entry as warranted. Performs necessary tests such as EKGs, Walk tests, etc., as appropriate to training level. Physical Requirements Typical clinical and administrative office setting. Skills & Abilities: High organizational talents, data collection, and analysis skills. Meticulous attention to detail. Excellent computer skills, including word processing. Ability to prioritize quickly and appropriately. Excellent communication and interpersonal skills. Systematic record-keeping. #J-18808-Ljbffr

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