A full-time Clinical Research Coordinator II is being recruited for a collaborative research team that is focused on assessing sleep patterns in historically sleep disparate populations, these populations include: racial/ethnic minoritized populations, less privileged socioeconomic status from any race/ethnicity subpopulation, underserved rural populations, and sexual and gender minoritized populations. The successful candidate will contribute to ongoing work with children and adolescents that will participate in longitudinal and observational studies assessing their sleep health, experiences of marginalization, and physiological arousal. Duties will involve direct work with research participants (recruitment, in-person data collection, qualitative interviews) in primary care settings, the hospital, and other community settings, as well as study coordination. Specific tasks may include: helping with IRB protocols, completing study visits, interviews, data management and analyses, and dissemination of research results. This position will involve close collaboration with the investigators as well as other research staff in the lab, Center for Child Health Equity and Outcomes Research at NCH, community leaders, and broader staff at NCH/Ohio State University. Several opportunities exist for mentorship and professional development for applicants who may be interested in gaining experience that will prepare them to apply for advanced graduate programs in medicine, public health, or psychology. Prefer individuals interested in remaining in position for at least two years. Applicants are encouraged to submit resumes with sufficient detail to demonstrate their academic record (i.e., college GPA) and relevant research or work experience. Cover letters are encouraged. The Clinical Research Coordinator’s primary responsibility is managing elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.
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ResponsibilitiesPRINCIPAL DUTIES AND RESPONSIBILITIES:
Performs research activities as outlined in the protocol; implementing and organizing clinical research studies assigned to him/her which includes but is not limited to:
Conducts clinical studies as outlined in the study protocol; performing study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; adheres to good clinical practices.Prepares and processes sleep and physiological monitoring data for use in research studies, if applicable to the study. Such activities may be performed independently and may require evening hours. c) Collects and controls research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures (if applicable) Assists in the recruitment plan and the in cost estimation; manages screening sheets and recruitment logs, and completes recruitment summary at study termination. Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection,Collaborates, coordinates, and schedules subject study visits with other lab team members and the PI/sub-I; Enrollment of subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations;Adheres to departmental quality control guidelinesEnsures that the investigator verifies that the subject meets inclusion/exclusion criteria; verified that the subject and/or legal guardian has provided informed consent/assent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate; Assists PI in education of other study personnel with regards to study responsibilities and keeps formal documentation of this training.Alerts and collaborates closely with the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination. Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits. Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder. Assists the principal investigator in the preparation of scientific publications and grant proposals. Coaches and mentors new clinical research coordinators and research interns/students.Performs other duties and maintains flexible schedule as required by a protocol or unit needs. QualificationsKNOWLEDGE , SKILLS AND ABILITIES REQUIRED
BA/BS preferred; Associates degree or equivalent work related experience required; 2 year experience in clinical research or health care field. Understanding of public health and health disparities related research preferred. Community-based and/or mixed methods research experience preferred.Skills required:
Working knowledge of PCs and word processing and data management software Verbal and written communication Goal-oriented; self-directiveInitiation, motivation, creativity Organizational and interpersonal Ability to actively participate as a team player Mentoring/training of new or visiting staffMINIMUM PHYSICAL REQUIREMENTS
Talking on phone/in person; frequently (34-100%) Sitting; frequently (34-100%) Standing/Walking; frequently (34-100%) Lifts objects weighing up to 25 pounds; occasionally (0-33%) Typing on keyboard; occasionally (0-33%)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.
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