QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE: High school diploma or general education degree (GED) required. One to two years related experience and/or training; or equivalent combination of education and experience in clinical research, including recruitment, reporting, specimen processing and handling and source documentation.
CERTIFICATES, LICENSES, AND REGISTRATIONS: Good Clinical Practice (GCP); IATA and NIH current certificates or obtained within 4 weeks of hire.
ESSENTIAL FUNCTIONS:
Essential functions are those tasks, duties and responsibilities that comprise the means of accomplishing the job’s purpose and objectives. Essential functions are critical or fundamental to the performance of the job. They are the major functions for which the person in the job is held accountable. Note: (other duties may be assigned, deleted or changed at any time, at the discretion of management, formally, or informally, either verbally or in writing).
1.Assists the Clinical Research Coordinator(s), Medical Director and Providers the research assistant will be responsible for supporting multiple research activites to assure efficacy and regulatory compliance of protocol, and data management projects as needed to meet the needs of the Clinical Research Department.
2.Ensure that patients are appropriately scheduled for study related activities in compliance with the protocol, while assuring confidentiality of patient information.
3.Recruitment of Study participants so must review and comprehend each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
4.Assists with sponsor prequalification visits, monitor visits, study termination visits.
5.Responsible for compilation, registration and submission of data within regulatory timelines; maintains current and accurate protocol documentation, monitors and ensures study compliance with intense monitoring of study specific requirements, and maintains a system for effective data flow associated with research protocols.
6.Assists with forms and data entry (EPIC, EDC, ect.). Assists with data clarification requests in a timely manner.
7.Is familiar and in compliance with clinical research and related activities are performed in accordance with Federal regulations, BFS, sponsoring agency and RMC policies and procedures.
8.Assists with required logs for patients and or studies and or Department. Assist with ordering and stocking of all materials for each clinical trial protocol and department needs.
9.Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
10.Prep source charts, ensuring the most recent version of the source is always utilized.
11.Assist with specimen processing, shipping and handling.
12.Assists with establishing and organizing study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required. Assists the Research Coordinator(s) and/or Principal Investigator(s) in submission of accurate and timely closeout documents to applicable Federal agencies, Riverside Medical Clinic for Sight, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures.
This opportunity offers the following:
Challenging and rewarding work environment
Growth and Development Opportunities within UHS and its Subsidiaries
Competitive Compensation
About Universal Health Services
One of the nation’s largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (UHS) has built an impressive record of achievement and performance. During the year, UHS was again recognized as one of the World’s Most Admired Companies by Fortune; and listed in Forbes ranking of America’s Largest Public Companies. Operating acute care hospitals, behavioral health facilities, outpatient facilities and ambulatory care access points, an insurance offering, a physician network and various related services located all over the U.S. States, Washington, D.C., Puerto Rico and the United Kingdom.
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