Senior Clinical Research Specialist
Work Shift:
DAYWork Schedule:
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
ESSENTIAL FUNCTIONS PERFORMED
• Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents.
• Maintains multiple trackers following the progress of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up visits, as applicable.
• Orders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and paper).
• Provides support to study vendors.
• Collects and reviews all regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelines.
• Follows up as required to resolve deficiencies.
• Ensures that regulatory documents are maintained and updated in a timely and appropriate manner.
• Ensures study team training records are kept current.
• Performs in-house duties to assist monitors, e.g., outstanding action items.
• Manages central IRB submissions and supports sites in IRB/EC submissions.
• May attend site visits to assist monitors, when applicable.
• Assists with the development of study and site tools.
• Contributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue resolution, etc.
• Assists in developing and overseeing study operational plan(s) as applicable (e.g., TMF plan).
• Contributes to study team for trial start-up, conduct, and close-out activities according to industry and departmental standards.
• Conducts study systems training(s).
• Contributes to creation of study documentation including informed consent, newsletters, etc.
• Provides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translations.
• Assists Project Managers with invoice receipt and review as applicable.
• Performs other duties and tasks, as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
Lifting -- Not to exceed 50 lbs. – local practice may apply.
Writing
Sitting
Standing
Bending
Visual acuity
Color perception
Depth perception
Reading
Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS
Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification.
A minimum of six (6) years of related work experience.
Current Good Clinical Practice (GCP) certification
Knowledge of US regulations, Good Clinical Practice and ICH guidelines.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Clinical trial experience.
PREFERRED QUALIFICATIONS
Medical Device clinical trial experience
COMPETENCIES
Verbal and written communication
Organization
Detail-oriented
Project task team participation
COMMENTS
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
As an eligible Merit employee, you can expect the following:
* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
* Medical/Dental & Other Insurances (eligible the first of month after 30 days)
* Low Cost Onsite Medical Clinic
* Two (2) Onsite Cafeterias
* Employee Garden | Gardening Classes
* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
* 401K | Health Savings Account
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
DAYWork Schedule:
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
ESSENTIAL FUNCTIONS PERFORMED
• Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents.
• Maintains multiple trackers following the progress of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up visits, as applicable.
• Orders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and paper).
• Provides support to study vendors.
• Collects and reviews all regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelines.
• Follows up as required to resolve deficiencies.
• Ensures that regulatory documents are maintained and updated in a timely and appropriate manner.
• Ensures study team training records are kept current.
• Performs in-house duties to assist monitors, e.g., outstanding action items.
• Manages central IRB submissions and supports sites in IRB/EC submissions.
• May attend site visits to assist monitors, when applicable.
• Assists with the development of study and site tools.
• Contributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue resolution, etc.
• Assists in developing and overseeing study operational plan(s) as applicable (e.g., TMF plan).
• Contributes to study team for trial start-up, conduct, and close-out activities according to industry and departmental standards.
• Conducts study systems training(s).
• Contributes to creation of study documentation including informed consent, newsletters, etc.
• Provides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translations.
• Assists Project Managers with invoice receipt and review as applicable.
• Performs other duties and tasks, as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
Lifting -- Not to exceed 50 lbs. – local practice may apply.
Writing
Sitting
Standing
Bending
Visual acuity
Color perception
Depth perception
Reading
Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS
Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification.
A minimum of six (6) years of related work experience.
Current Good Clinical Practice (GCP) certification
Knowledge of US regulations, Good Clinical Practice and ICH guidelines.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Clinical trial experience.
PREFERRED QUALIFICATIONS
Medical Device clinical trial experience
COMPETENCIES
Verbal and written communication
Organization
Detail-oriented
Project task team participation
COMMENTS
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
As an eligible Merit employee, you can expect the following:
* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
* Medical/Dental & Other Insurances (eligible the first of month after 30 days)
* Low Cost Onsite Medical Clinic
* Two (2) Onsite Cafeterias
* Employee Garden | Gardening Classes
* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
* 401K | Health Savings Account
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.