Senior Clinical Research Associate - Remote
About ClinChoice ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide.
With a 25-year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance.
ClinChoice has established major delivery centers across US, China, Europe, Canada, India, Japan and the Philippines.
It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.
We are looking for a dynamic person to join our in-house team as a Senior Clinical Research Associate (SCRA).
This individual will be responsible for monitoring clinical activities at the study sites.
This role requires previous respiratory experience.
Responsibilities include site visits, monitoring, communication, and deliverables for the assigned study sites.
Serves as a member of the clinical study team and is the liaison between Clinical Operations and study site personnel for the specific clinical project.
Work hours are 40 hours/week.
Main Job Tasks and
Responsibilities:
Assist in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the sites.
Perform training of site staff in all study procedures in order to ensure compliance with the protocol and ICH-GCP.
Conduct and report periodic monitoring visits in the field and review accuracy, eligibility, completeness and quality of the Case Report Forms (CRF) to ensure data integrity and subject safety.
Adapt and translate Patient Information Leaflets and Informed Consent Forms.
Cooperate with the site staff for ensuring the proper reporting from the site of any safety issues (adverse events and adverse reactions such as AEs/SAEs/SUSARs, etc.
) and their follow up, guaranteeing timely and appropriate handling of safety issues.
Escalate any issues to the relevant project team members.
Assist in contract negotiation with sites on study budget after appropriate and documented training.
Support the submission progress for projects (or region).
Education, Experience and Skills:
University Degree in scientific, medical or paramedical discipline Extensive proven experience with 8
years as a CRA and with site management activities Previous experience with complex therapeutic areas and respiratory trials Excellent knowledge of clinical trial operations, ICH-GCP guidelines and other applicable regulatory requirements Willingness to travel ClinChoice is an Equal Opportunity Employer / Committed to Diversity Recommended Skills Case Report Forms Clinical Research Clinical Trials Clinical Works Patient Information Leaflet Regulatory Requirements Estimated Salary: $20 to $28 per hour based on qualifications.
With a 25-year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance.
ClinChoice has established major delivery centers across US, China, Europe, Canada, India, Japan and the Philippines.
It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.
We are looking for a dynamic person to join our in-house team as a Senior Clinical Research Associate (SCRA).
This individual will be responsible for monitoring clinical activities at the study sites.
This role requires previous respiratory experience.
Responsibilities include site visits, monitoring, communication, and deliverables for the assigned study sites.
Serves as a member of the clinical study team and is the liaison between Clinical Operations and study site personnel for the specific clinical project.
Work hours are 40 hours/week.
Main Job Tasks and
Responsibilities:
Assist in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the sites.
Perform training of site staff in all study procedures in order to ensure compliance with the protocol and ICH-GCP.
Conduct and report periodic monitoring visits in the field and review accuracy, eligibility, completeness and quality of the Case Report Forms (CRF) to ensure data integrity and subject safety.
Adapt and translate Patient Information Leaflets and Informed Consent Forms.
Cooperate with the site staff for ensuring the proper reporting from the site of any safety issues (adverse events and adverse reactions such as AEs/SAEs/SUSARs, etc.
) and their follow up, guaranteeing timely and appropriate handling of safety issues.
Escalate any issues to the relevant project team members.
Assist in contract negotiation with sites on study budget after appropriate and documented training.
Support the submission progress for projects (or region).
Education, Experience and Skills:
University Degree in scientific, medical or paramedical discipline Extensive proven experience with 8
years as a CRA and with site management activities Previous experience with complex therapeutic areas and respiratory trials Excellent knowledge of clinical trial operations, ICH-GCP guidelines and other applicable regulatory requirements Willingness to travel ClinChoice is an Equal Opportunity Employer / Committed to Diversity Recommended Skills Case Report Forms Clinical Research Clinical Trials Clinical Works Patient Information Leaflet Regulatory Requirements Estimated Salary: $20 to $28 per hour based on qualifications.
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