Post : Clinical Research Associate
Job Description:
• Working fully outsourced to one of our global client, the Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.
• With full ownership of investigator sites for assigned studies, the Clinical Research Associate’s (CRA) involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, the Clinical Research Associate (CRA) fosters effective relationships with investigator site staff to ensure that key clinical metrics are met.
• This involves establishing innovative ways of increasing site and patient recruitment. When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team.
• The Clinical Research Associate may also design and deliver training to site staff, when appropriate.
• The Clinical Research Associate (CRA) ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines. Operating as a key part of a global study team, the CRA plays a fundamental role in our client’s drug development process.
Job Description:
• Working fully outsourced to one of our global client, the Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.
• With full ownership of investigator sites for assigned studies, the Clinical Research Associate’s (CRA) involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, the Clinical Research Associate (CRA) fosters effective relationships with investigator site staff to ensure that key clinical metrics are met.
• This involves establishing innovative ways of increasing site and patient recruitment. When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team.
• The Clinical Research Associate may also design and deliver training to site staff, when appropriate.
• The Clinical Research Associate (CRA) ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines. Operating as a key part of a global study team, the CRA plays a fundamental role in our client’s drug development process.
Candidate Profile
The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
Prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Fluency in English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.
The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
Prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Fluency in English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.
Additional Information
Location : Mumbai
Industry Type : Clinical research
Functional Area : CRA
End Date : 20th January, 2019
Location : Mumbai
Industry Type : Clinical research
Functional Area : CRA
End Date : 20th January, 2019
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