Clinical Research Associate
Full Time
Chapel Hill, NC 27599
$48,000 - $53,342 a year
Posted Just posted
Job description
Posting Information
Department
Surgery - Vascular-414060
Career Area
Research Professionals
Is this an internal only recruitment?
No
Posting Open Date
05/18/2023
Application Deadline
05/26/2023
Position Type
Permanent Staff (SHRA)
Position Title
Soc/Clin Research Assistant - Advanced
Salary Grade Equivalent
GN10
Working Title
Social/Clinical Research Assistant
Position Number
20055875
Vacancy ID
P017465
Full-time/Part-time Permanent/Time-Limited
Full-Time Permanent
If time-limited, estimated duration of appointment
Hours per week
40
Work Schedule
Monday – Friday, 8am – 5pm
Work Location
Chapel Hill, NC
Position Location
North Carolina, US
Hiring Range
$48,000 - $53,342
Pay Band Information
To learn more about the pay band for this branch and role, please see
the Career Banding rates spreadsheet.
Position Summary Information
Primary Purpose of Organizational Unit
The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.
OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.
Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.
OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.
Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.
Position Summary
The Research Assistant will be responsible for assisting with the startup and management of clinical trials. This will include reviewing and understanding research protocols, obtaining clinical trial data, interacting with clinical trial patients, answering trial queries, registering patients in EPIC/CRMS for accurate billing, submitting patient data, maintaining and organizing data for regulatory compliance, preparing ethics board applications, and maintaining study supply inventory. This will require following detailed instruction outlined by the research team, acting independently within the scope of the clinical trial and instruction from the principal investigators, and completing related training such as Human Research Participant Protection and HIPM training.
The Assistant works with delegated authority from the Principal Investigator to ensure that these clinical trials are conducted in a manner to meet all federal, sponsor and university requirements. Principal Investigator will provide support and oversight as needed.
The Assistant acts as a primary contact for the assigned trials for the sponsor, the investigators, and subjects; activities include identifying and consenting patients with investigators, attending off-site study meetings as required, scheduling and completing telephone or research clinic follow-up visits, attending study teleconferences/training, facilitating with investigator and trials personnel training, performing data abstraction and completion of CRFs, adverse event/outcome monitoring and reporting, maintenance of subject research charts, and facilitating study monitor visits with the Principal Investigator.
Financial management for budgeting/payment tracking for all trials, including registries, the assistant will work with the supervisor to track subject visits and site payments, prepare and submit site invoices, and facilitate and track any required subject visit payments with supervisor oversight.
In assistance of the supervisors and the Pl, the Assistant will be responsible for assistance regulatory maintenance of the assigned sub-set of trials and other trials as required by work needs. The Assistant with help prepare all documents required for IRB initial and continuing review (IRB application, consent & HIPAA forms) and protocol amendments/study updates, providing clarifications to IRB contingencies, coordinating revisions with the supervisor, Principal Investigator, and sponsor. The Assistant will, under the guidance of the Principal Investigator, prepare and submit regulatory documents as required by the trial sponsor, including financial disclosures, delegation of authority logs, training logs, and CVs/licenses. The Assistant must help ensure timely and efficient review and processing of regulatory and IRB submissions in order to limit start up time and ensure seamless overall implementation of clinical trials with supervisor and Principal Investigator guidance.
The Assistant works with delegated authority from the Principal Investigator to ensure that these clinical trials are conducted in a manner to meet all federal, sponsor and university requirements. Principal Investigator will provide support and oversight as needed.
The Assistant acts as a primary contact for the assigned trials for the sponsor, the investigators, and subjects; activities include identifying and consenting patients with investigators, attending off-site study meetings as required, scheduling and completing telephone or research clinic follow-up visits, attending study teleconferences/training, facilitating with investigator and trials personnel training, performing data abstraction and completion of CRFs, adverse event/outcome monitoring and reporting, maintenance of subject research charts, and facilitating study monitor visits with the Principal Investigator.
Financial management for budgeting/payment tracking for all trials, including registries, the assistant will work with the supervisor to track subject visits and site payments, prepare and submit site invoices, and facilitate and track any required subject visit payments with supervisor oversight.
In assistance of the supervisors and the Pl, the Assistant will be responsible for assistance regulatory maintenance of the assigned sub-set of trials and other trials as required by work needs. The Assistant with help prepare all documents required for IRB initial and continuing review (IRB application, consent & HIPAA forms) and protocol amendments/study updates, providing clarifications to IRB contingencies, coordinating revisions with the supervisor, Principal Investigator, and sponsor. The Assistant will, under the guidance of the Principal Investigator, prepare and submit regulatory documents as required by the trial sponsor, including financial disclosures, delegation of authority logs, training logs, and CVs/licenses. The Assistant must help ensure timely and efficient review and processing of regulatory and IRB submissions in order to limit start up time and ensure seamless overall implementation of clinical trials with supervisor and Principal Investigator guidance.
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
- Experience with database entry or management.
- Experience with MS Office.
- Ability to work with a variety of professionals.
- Ability to work in a collaborative and academic group to discuss research in a meaningful way to promote efficiency for trial start up and during active trials.
- Ability to interpret findings.
- Knowledge and ability to recommend or implement technical modifications or alternatives to data/information collection and analysis.
Preferred Qualifications, Competencies, and Experience
- Prior experience with research and IRB.
- Full Knowledge of the research principles and methods to interpret, coordinate, and/or supervise the collection and analysis of data/information related to defined research areas.
- Full knowledge of statistics and related information technology to oversee the entry, collection, and analysis of data/information related to defined research area.
- The ability to design data/information collection and/or quality control procedures.
- Ability to identify and report variations or discrepancies in the data/information within defined research parameters.
- Ability to organize and prepare data/information for analyses.
- Ability to provide analysis on data/information collected.
- Ability to document procedures and/or methods when atypical data/information methods are used.
- Ability to report situations when atypical methods are used and the frequency of use.
- Ability to analyze and reconcile data/information for reports from different internal and external sources.
- Ability to serve as a project/team leader to the Principal Investigators.
- Technical knowledge and skill in specific/content area(s) and ability to keep current with developments and trends in area(s) of research.
- Working knowledge of statistics and related information technology. Knowledge may be acquired through academic and/or on-the-job training.
- Full knowledge of the research principles and methods to interpret, coordinate, and/or supervise the collection and analysis of data/information related to defined research area(s).
- Knowledge and ability to recommend or implement technical modifications or alternatives to data/information collection and analysis.
- Knowledge of statistics and related information technology to oversee the entry, collection, and analysis of data/information related to defined research area.
- Ability to convey accurate information through a variety of means during all phases of research including data/information collection, processing, and dissemination and reporting to individuals or groups.
- Ability to ensure that information related to research is understood.
- Ability to listen and respond appropriately to others to make the information understandable.
- Ability to lead, consult and make recommendations in the area of research.
- Ability to serve as primary presenter to various audiences.
Required Licenses/Certifications
Special Physical/Mental Requirements
N/A
Campus Security Authority Responsibilities
Not Applicable.
Position/Schedule Requirements
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