Job description
Key Responsibilities:
Assist with site selection activities, including site qualification visits.
Serve as first line of contact for study sites.
Assist with preparation of documents for regulatory and IRB submissions as required.
Perform site initiation visits and other site training as needed.
Assist with the development of study-specific, risk-based monitoring plan, study operations manual, tracking forms, and other study related documents as required.
In keeping with best practices of Risk Based Monitoring, conduct on-site and remote monitoring to review clinical data for accuracy, completeness and discrepancy resolution.
Submit monitoring visit reports and monitoring visit follow-up letters within required timelines.
Assure study site adherence to the protocol, GCP, procedural documents and recommend necessary actions to bring about compliance or improve processes.
Anticipate/identify potential problems, implement corrective and preventive actions and escalate where appropriate.
Assist with vaccine supply management and ensure proper storage, dispensation, and accountability of all investigational product(s) and trial-related material at study sites.
Receive and review weekly enrollment updates during site/study enrollment period; update team.
Liaise with sites and IAVI data management or other departments, as requested, to resolve data queries.
Maintain good relations with IAVI collaborators and trial sites to facilitate site development and execution of clinical trials.
Participate in teleconferences, Investigator Meetings, GCP trainings, Study Close-Out visits and additional visits to sites as needed.
Coordinate with the IAVI Team and sites to ensure proper and timely submissions to IRBs, review and assist in preparation of appropriate responses for re-submission if necessary.
Ensure IAVI reviews and approves all documents prior to submission and implementation at the site. Receive/obtain copies of all IRB submissions.
Ensure proper reporting, follow-up internally and assist in management of Adverse Events (AEs)/Serious Adverse Events (SAEs) per protocol. Ensure SAEs, safety update reports and other new information or sponsor reports are provided to and received by the sites for reporting to ethics, as needed.
Ensure all Serious Adverse Events (SAE) reports are reviewed, signed off by the responsible physician and filed within required timelines
Create and maintain trial and master files in compliance with ICH guidelines
Contribute to the Medical Affairs departmental Standard Operating Procedures for conduct of clinical trials based on IAVI templates and ensures adherence to regulations/guidelines for GCP.
Other duties as assigned.
Requirements:
Required Education Bachelor’s degree or BS in scientific field, nursing degree, or advanced degree in relevant field.
2 years relevant experience
Experience with clinical research data, investigational product, or maintenance of investigator site files.
2+ years clinical monitoring experience
Experience with HIV related or vaccine research.
Experience with HIV related lab procedures and clinical safety laboratory testing desirable.
Experience working on project teams
Experience training others
Computer literate
Critical thinker
Attention to detail
Excellent verbal and written communication
Strong organizational skills
Able to take responsibility for completion of tasks with high quality according to established program timelines
Identify problems and possible solutions and assess the impact on timelines
Adept at electronic data capture (EDC) systems, electronic Trial Master Files, electronic Quality Management Systems
Good Clinical Practices (GCP)
Good Documentation Practices
Proficient in Microsoft Outlook, Word, Excel, PowerPoint
HIV and/or global health
Proficient in QA/QC systems and practices
MS Project
Willingness to travel (up to 50%)
Able to adapt to diverse educational and cultural backgrounds, and maintain a high standard of professional conduct as a representative of IAVI
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Specific visions abilities require by this job include close vision, distance vision, color vision, peripheral vision, depth perception and abilities to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
