LCCC – Clinical Trials-426806
Career Area:
Research Professionals
Is this an internal only recruitment?:
No
Posting Open Date :
02/05/2024
Application Deadline:
02/09/2024
Position Type:
Permanent Staff (SHRA)
Position Title:
Soc/Clin Research Assistant – Advanced
Salary Grade Equivalent:
GN10
Working Title:
Data Coordinator
Position Number:
20049139
Vacancy ID:
P018646
Full-time/Part-time Permanent/Time-Limited:
Full-Time Permanent
Hours per week:
40
Work Schedule:
Monday – Friday,8:00AM – 5:00PM
Work Location:
Chapel Hill, NC
Position Location:
North Carolina, US
Hiring Range:
$48,008 – $63,349
Pay Band Information:
To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.
Be a Tar Heel!:
A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation’s top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.
Primary Purpose of Organizational Unit:
The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is one of 47 National Cancer Institute (NCI)-designated comprehensive cancer centers in the country. The Center’s mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach.
UNC Lineberger’s Clinical Protocol Office is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The Protocol Office is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.
Position Summary:
This position will independently coordinate complex clinical research studies and perform site initiation activities, help create data collection forms, coordinate the comprehensive protocol patient record charts by supervising collection of all inter-departmental data records for assigned studies. Additionally, the position will independently assess patients for eligibility for inclusion in studies with minimal supervision. The position will oversee the registration and randomizing of patients into studies, assure accurate data is documented in accordance with clinical research protocols and federal regulations. The position will oversee and/or perform the proper processing and shipping of patient laboratory samples for assigned protocols correctly according to procedures outlined in the protocol/laboratory manual in a timely fashion. The position serves as liaison between Protocol Office and external sponsors/customers and regulatory agencies and is responsible for scheduling and facilitating internal and external monitoring visits and audits/inspections.
Minimum Education and Experience Requirements:
Bachelor’s degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Required Qualifications, Competencies, and Experience:
Knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols;
High level of accuracy and attention to detail;
Strong computer skills;
Ability to gather data and document procedures;
Ability to plan work and coordinate multiple projects;
Ability to contribute to preparation and delivery of reports, trainings and SOPs;
Customer oriented and ability to work in a team environment;
Ability to communicate effectively and professionally verbally and in writing;
Ability to work on evenings, weekends and/or holidays occasionally required.
Preferred Qualifications, Competencies, and Experience:
Previous experience with therapeutic clinical research involving drugs and/or devices.
Experience in Phase I, II, and III clinical research.
Experience navigating medical records and data extraction.
Data coordinator experience or experience in oncology clinical trials.
Campus Security Authority Responsibilities:
Not Applicable.
Position/Schedule Requirements:
Clinic – UNCH or ACC, Evening work occasionally, Exposure to Bloodborne Pathogens, Exposure to Hazardous Materials, Laboratory, Overtime occasionally, Weekend work occasionally
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