What are the responsibilities and job description for the Research Assistant (Regulatory) position at CHEManager International?
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Job Description Summary
The research assistant position is an entry-level, full-time role for professionals who would like to gain clinical research experience. OhioHealth Research Institute (OHRI) is a centralized department that fosters medical treatments and enhanced patient experiences through clinical trials, scholarly activity and other programs. The purpose of this position is to provide coordination and support for OHRI Research Operations as it relates to therapeutic/interventional clinical trials, academic research, regulatory, quality assurance and other research operations roles as needed. This position is responsible for assisting research coordinators, regulatory consultants, research specialists, research activation coordinator and other research personnel (as determined by research leadership) in regard to specific team/project activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures.
Manages complex administrative tasks in support of research administration and clinical trials, including but not limited to screening patients, entering/abstracting data, processing research specimens, maintaining clinical trial inventory and documentation (such as specimen kits, long term storage/archival), document filing, assisting with basic IRB submissions, scheduling and coordinating project meetings and assisting with other core administrative activities in support of research operations. Based on performance and demonstrated competency, OHRI research assistants who do not possess a bachelor's degree may be eligible to apply for a clinical research coordinator, regulatory coordinator or other applicable position within OHRI.
Responsibilities And Duties
As assigned by manager, the research assistant is responsible with coordinating the following objectives to support OHRI research operations:
Supports research staff with execution of high acuity/enrolling clinical trials. This includes but is not limited to data entry, processing and shipping of laboratory samples and activating and closing out research studies.
Extracts and records physical findings, laboratory data and other details essential to each study onto required data collection forms/software applications within the designated time period.
Assists research staff with reporting adverse events and protocol violations / deviations to the study sponsor and investigator to ensure the health, safety and welfare of the participant.
Participate in protocol meetings to review study-related procedures and visit flow.
Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation.
After study closeout visits, prepares study documents for archiving.
Supports OHRI Regulatory team in maintaining investigator credentials and other supporting documents as needed.
Interacts and maintains liaison with colleagues, investigators, staff and outside/community agencies in facilitating department objectives
Assists with scheduling site monitor visits for clinical teams as needed.
Provides administrative support for shipping logistics, temperature monitoring logs and tracking metrics as needed.
Assists in audit preparedness activities for OHRI.
Assists with maintaining study records according to sponsor and/or regulations.
Assist in the development of reporting metrics.
Assists with recording meeting minutes and timely distribution.
Attends relevant training courses on policy and compliance.
Other administrative duties as assigned.
As a High Reliability Organization (HRO), responsibilities require focus on safety, quality and efficiency in performing job duties.
The job profile provides an overview of responsibilities and duties and is not intended to be an exhaustive list and is subject to change at any time
Minimum Qualifications
High School or GED (Required)
Additional Job Description
SPECIALIZED KNOWLEDGE
Exceptional organization and time management skills. Detail-oriented person with the ability to work independently on multiple tasks. Ability to understand and communicate requirements to others. Excellent verbal, interpersonal and written communication skills. Strong computer skills with high level of proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and database applications. High level of initiative and ownership with the ability to self-motivate. Works well independently and in team settings.
Work Shift
Day
Scheduled Weekly Hours
40
Department
Research Administration
Join us!
OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment
Job Description Summary
The research assistant position is an entry-level, full-time role for professionals who would like to gain clinical research experience. OhioHealth Research Institute (OHRI) is a centralized department that fosters medical treatments and enhanced patient experiences through clinical trials, scholarly activity and other programs. The purpose of this position is to provide coordination and support for OHRI Research Operations as it relates to therapeutic/interventional clinical trials, academic research, regulatory, quality assurance and other research operations roles as needed. This position is responsible for assisting research coordinators, regulatory consultants, research specialists, research activation coordinator and other research personnel (as determined by research leadership) in regard to specific team/project activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures.
Manages complex administrative tasks in support of research administration and clinical trials, including but not limited to screening patients, entering/abstracting data, processing research specimens, maintaining clinical trial inventory and documentation (such as specimen kits, long term storage/archival), document filing, assisting with basic IRB submissions, scheduling and coordinating project meetings and assisting with other core administrative activities in support of research operations. Based on performance and demonstrated competency, OHRI research assistants who do not possess a bachelor's degree may be eligible to apply for a clinical research coordinator, regulatory coordinator or other applicable position within OHRI.
Responsibilities And Duties
As assigned by manager, the research assistant is responsible with coordinating the following objectives to support OHRI research operations:
Supports research staff with execution of high acuity/enrolling clinical trials. This includes but is not limited to data entry, processing and shipping of laboratory samples and activating and closing out research studies.
Extracts and records physical findings, laboratory data and other details essential to each study onto required data collection forms/software applications within the designated time period.
Assists research staff with reporting adverse events and protocol violations / deviations to the study sponsor and investigator to ensure the health, safety and welfare of the participant.
Participate in protocol meetings to review study-related procedures and visit flow.
Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation.
After study closeout visits, prepares study documents for archiving.
Supports OHRI Regulatory team in maintaining investigator credentials and other supporting documents as needed.
Interacts and maintains liaison with colleagues, investigators, staff and outside/community agencies in facilitating department objectives
Assists with scheduling site monitor visits for clinical teams as needed.
Provides administrative support for shipping logistics, temperature monitoring logs and tracking metrics as needed.
Assists in audit preparedness activities for OHRI.
Assists with maintaining study records according to sponsor and/or regulations.
Assist in the development of reporting metrics.
Assists with recording meeting minutes and timely distribution.
Attends relevant training courses on policy and compliance.
Other administrative duties as assigned.
As a High Reliability Organization (HRO), responsibilities require focus on safety, quality and efficiency in performing job duties.
The job profile provides an overview of responsibilities and duties and is not intended to be an exhaustive list and is subject to change at any time
Minimum Qualifications
High School or GED (Required)
Additional Job Description
SPECIALIZED KNOWLEDGE
Exceptional organization and time management skills. Detail-oriented person with the ability to work independently on multiple tasks. Ability to understand and communicate requirements to others. Excellent verbal, interpersonal and written communication skills. Strong computer skills with high level of proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and database applications. High level of initiative and ownership with the ability to self-motivate. Works well independently and in team settings.
Work Shift
Day
Scheduled Weekly Hours
40
Department
Research Administration
Join us!
- if your passion is to work in a caring environment
- if you believe that learning is a life-long process
- if you strive for excellence and want to be among the best in the healthcare industry
OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment