Clinical Research Associate
Posted on Sep 14, 2024 by Pharmaceutical Research Associates, Inc
Emelle, AL
Research
Immediate Start
Annual Salary
Full-Time
Overview:
Clinical Research Associate – Johannesburg, South Africa
As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.
Responsibilities:
What you will be doing:
Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
Work collaboratively with investigative sites to develop strong, long-term, working relationships.
Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
Help identify and qualify potential investigators.
Perform all type of visits from Pre-Study to Close out.
Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
Assist with start-up activities, including essential document review and collection as requested.
Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.
Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.
Qualifications:
To enable success in this position you will have:
Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
A minimum of 3 years of on-site independent monitoring experience is required in medium-sized studies, including study start-up and close-out.
You will be educated to degree level, within an applicable field.
Excellent written and verbal communication
Ability to work to tight deadlines.
Availability to travel least 60% of the time and should possess a valid driving license
A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Ideally having gained expertise in multi-therapeutic areas.
Must be based in Johannesburg South Africa.border travel
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
Life assurance
Visit our careers website to read more about the benefits of working at ICON: (url removed)
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid
Clinical Research Associate – Johannesburg, South Africa
As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.
Responsibilities:
What you will be doing:
Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
Work collaboratively with investigative sites to develop strong, long-term, working relationships.
Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
Help identify and qualify potential investigators.
Perform all type of visits from Pre-Study to Close out.
Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
Assist with start-up activities, including essential document review and collection as requested.
Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.
Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.
Qualifications:
To enable success in this position you will have:
Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
A minimum of 3 years of on-site independent monitoring experience is required in medium-sized studies, including study start-up and close-out.
You will be educated to degree level, within an applicable field.
Excellent written and verbal communication
Ability to work to tight deadlines.
Availability to travel least 60% of the time and should possess a valid driving license
A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Ideally having gained expertise in multi-therapeutic areas.
Must be based in Johannesburg South Africa.border travel
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
Life assurance
Visit our careers website to read more about the benefits of working at ICON: (url removed)
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid
Reference: 199215545
https://jobs.careeraddict.com/post/95172529
Clinical Research Associate
Posted on Sep 14, 2024 by Pharmaceutical Research Associates, Inc
Emelle, AL
Research
Immediate Start
Annual Salary
Full-Time
Overview:
Clinical Research Associate – Johannesburg, South Africa
As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.
Responsibilities:
What you will be doing:
Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
Work collaboratively with investigative sites to develop strong, long-term, working relationships.
Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
Help identify and qualify potential investigators.
Perform all type of visits from Pre-Study to Close out.
Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
Assist with start-up activities, including essential document review and collection as requested.
Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.
Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.
Qualifications:
To enable success in this position you will have:
Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
A minimum of 3 years of on-site independent monitoring experience is required in medium-sized studies, including study start-up and close-out.
You will be educated to degree level, within an applicable field.
Excellent written and verbal communication
Ability to work to tight deadlines.
Availability to travel least 60% of the time and should possess a valid driving license
A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Ideally having gained expertise in multi-therapeutic areas.
Must be based in Johannesburg South Africa.border travel
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
Life assurance
Visit our careers website to read more about the benefits of working at ICON: (url removed)
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid
Clinical Research Associate – Johannesburg, South Africa
As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.
Responsibilities:
What you will be doing:
Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
Work collaboratively with investigative sites to develop strong, long-term, working relationships.
Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
Help identify and qualify potential investigators.
Perform all type of visits from Pre-Study to Close out.
Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
Assist with start-up activities, including essential document review and collection as requested.
Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.
Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.
Qualifications:
To enable success in this position you will have:
Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
A minimum of 3 years of on-site independent monitoring experience is required in medium-sized studies, including study start-up and close-out.
You will be educated to degree level, within an applicable field.
Excellent written and verbal communication
Ability to work to tight deadlines.
Availability to travel least 60% of the time and should possess a valid driving license
A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Ideally having gained expertise in multi-therapeutic areas.
Must be based in Johannesburg South Africa.border travel
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
Life assurance
Visit our careers website to read more about the benefits of working at ICON: (url removed)
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid
Reference: 199215545
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