Clinical Research Assistant 2-USD at Mindlance
Idaho, ID 83201
About the Job
Essential Duties & Responsibilities:
Conducts ongoing remote or on-site monitoring, performs regulatory document reviews, 100% source data verification, assesses protocol adherence of assigned clinical sites.
o Predominantly remote monitoring: SDV, reg doc review, etc. For short periods,up to 75% on-site monitoring, dependent on sites capability and study need
Monitoring activities/shifts may be required outside standard shift hours.
Generates a weekly monitoring report which may include gathering input from other team members involved in monitoring and supporting the clinical study site
Contributes to weekly site progress report
Ensures collection of all reg docs, submits to TMF per sponsors procedures, and confirms proper entry into TMF
Reviews site ISF and ensures completeness and consistency w sponsor TMF
Works independently to manage assigned clinical tasks and deliverables to meet clinical timelines.
Collaborates effectively with peers and leadership across departments and across clinical study sites.
Experience and Education Requirements:
Typically requires a bachelors degree in a technical discipline, and a minimum of 2-5 years related experience or Masters degree and minimum 1 year experience.
Preferred Qualifications:
Professional certification (e.g. CCRA, CCRP, PMP, ACRP, SoCRA, RAPS)
Experience with clinical trials in the therapeutic area of Diabetes
Clinical Trial Management System (CTMS) experience
Minimum 1 year of on-site monitoring experience
Manage multiple, diversified tasks concurrently and to prioritize projects and tasks effectively.
Current GCP (Good Clinical Practice) Training
Conducts ongoing remote or on-site monitoring, performs regulatory document reviews, 100% source data verification, assesses protocol adherence of assigned clinical sites.
o Predominantly remote monitoring: SDV, reg doc review, etc. For short periods,up to 75% on-site monitoring, dependent on sites capability and study need
Monitoring activities/shifts may be required outside standard shift hours.
Generates a weekly monitoring report which may include gathering input from other team members involved in monitoring and supporting the clinical study site
Contributes to weekly site progress report
Ensures collection of all reg docs, submits to TMF per sponsors procedures, and confirms proper entry into TMF
Reviews site ISF and ensures completeness and consistency w sponsor TMF
Works independently to manage assigned clinical tasks and deliverables to meet clinical timelines.
Collaborates effectively with peers and leadership across departments and across clinical study sites.
Experience and Education Requirements:
Typically requires a bachelors degree in a technical discipline, and a minimum of 2-5 years related experience or Masters degree and minimum 1 year experience.
Preferred Qualifications:
Professional certification (e.g. CCRA, CCRP, PMP, ACRP, SoCRA, RAPS)
Experience with clinical trials in the therapeutic area of Diabetes
Clinical Trial Management System (CTMS) experience
Minimum 1 year of on-site monitoring experience
Manage multiple, diversified tasks concurrently and to prioritize projects and tasks effectively.
Current GCP (Good Clinical Practice) Training