[Hiring] Clinical Trial Associate @IAVI

Role Description

Are you a Clinical Operations professional who is eager to make an impact in a mission-driven organization? IAVI is seeking an ambitious Clinical Trial Associate to execute operational activities in support of clinical trial execution. The CTA works closely with the Clinical Trial Manager, CRAs, and clinical team to maintain the eTMF, track site documents, keep meeting minutes, and handle other ad-hoc clinical study team activities. The CTA is key in supporting the execution of highly complex clinical trials, including the onboarding and mentoring of new clinical operations staff.

Key Responsibilities:

• Serve as eTMF business administrator, manage system updates, train and onboard internal and external staff, and manage access control.
• Collect and track regulatory documents, other essential documents, and lead reviews of the eTMF ensuring all required documentation is on file.
• Liaise with site staff, investigators, Contract Research Organizations (CROs), and other vendors/collaborators as needed, maintaining accurate and timely completion of tasks assigned.
• Provide administrative and logistical support for teleconferences, internal and external meetings, trainings, or other meetings, and track supplies and equipment for the sites.
• Assist the clinical operations team in creating study documents while providing general support of the team's use of the eTMF and QualityDocs supporting workflows and management of metadata.
• Contribute to clinical study operations through tasks such as project tracking, audits, and maintenance of regulatory databases such as ClinicalTrials.gov.
• Anticipate/identify potential problems, write deviations, implement corrective actions, and escalate where appropriate.
• Serve as a member of the SOP task force as needed, contributing to the Clinical Development departmental Standard Operating Procedures for conduct of clinical trials, ensuring adherence to regulations/guidelines for GCP.
• Develop, maintain, and distribute reports from eTMF on both trial and organizational level to support documentation and metrics for multiple IAVI stakeholders.
• Serve as the business administrator of the LMS, providing programming support and generate reports for both CD training items and protocol specific training items.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree is required, preferably in a scientific field.
• Minimum 2 years of clinical operations experience.
• Experience as Clinical Trial Associate or in other clinical trials-related administrative support or equivalent is required.

Requirements

• Demonstrated understanding of clinical trial operations and research principles is required.
• Strong organizational skills, including the ability to work on multiple projects with overlapping schedules and flexibility, as well as to be able to change priorities to meet deadlines and organizational needs is required.
• Ability to work both independently and collaboratively in large, complex, cross-functional project teams is required.
• Attention to detail is required.
• Excellent verbal and written communication skills are required.
• Ability to complete tasks on time and with high quality is required.
• Critical thinking skills, with the ability to identify problems and possible solutions, and assess impact on timelines is required.
• Ability to work effectively with teams of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of IAVI is required.
• Computer and technological literacy, proficiency in Microsoft Office Suite, and ability to quickly learn and master new systems is required.
• Experience in electronic Trial Master File software such as Veeva or similar eTMF system is highly desirable.

Benefits

• Salary is paid in local currency, and is commensurate and competitive with the local labor market.
• Generous retirement savings plan employer contributions.
• Competitive health, dental and vision insurance plans.
• Competitive paid time off policy.
• Potential for annual bonuses based on performance.
• Other benefits as detailed on IAVI's career page.