Junior Clinical Research Associate Sponsor-dedicated
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Key skills for this role
About the Role
IQVIA is seeking a Junior Clinical Research Associate to perform site monitoring and management for clinical studies. The role involves ensuring sites comply with protocols, regulations, and sponsor requirements.
Key Skills for This Role
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and regulatory requirements
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs
- Administer protocol and related study training to assigned sites and establish regular lines of communication
- Evaluate the quality and integrity of study site practices related to proper conduct of the protocol and adherence to regulations
- Manage progress of assigned studies by tracking regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution
- Ensure copies/originals of site documents are available for filing in TMF and verify ISF maintenance
- Create and maintain documentation regarding site management, monitoring visit findings, and action plans
- Collaborate and liaise with study team members for project execution support
Requirements
- High School Diploma or equivalent; Degree in scientific discipline or health care preferred
- At least a few months to one year of on site monitoring experience
- Good knowledge of GCP and ICH guidelines
- Computer skills including proficiency in Microsoft Word, Excel, PowerPoint, and use of laptop and iPhone/iPad
- Written and verbal communication skills including good command of Arabic and English
- Organizational and problem solving skills
- Effective time and financial management skills
Full Job Posting
Job Overview
- Perform monitoring and site management work to ensure sites conduct studies and report data as required by protocol, regulations, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and regulatory requirements.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs.
- Administer protocol and related study training to assigned sites and establish regular lines of communication.
- Evaluate the quality and integrity of study site practices related to proper conduct of the protocol and adherence to regulations.
- Manage progress of assigned studies by tracking regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution.
- Ensure copies/originals of site documents are available for filing in TMF and verify ISF maintenance.
- Create and maintain documentation regarding site management, monitoring visit findings and action plans.
- Collaborate and liaise with study team members for project execution support.
- May be accountable for supporting development of project subject recruitment plan on a per site basis.
- May be accountable for site financial management according to executed clinical trial agreement.
Qualifications
- High School Diploma or equivalent; Degree in scientific discipline or health care preferred.
- Requires at least a few months to one year of on site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of GCP and ICH guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in Microsoft Word, Excel, PowerPoint, and use of laptop and iPhone/iPad.
- Written and verbal communication skills including good command of Arabic and English.
- Organizational and problem solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships.
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