POSITION SUMMARY: The Clinical Research Associate (CRA) is responsible for performing both onsite and remote monitoring of clinical sites to ensure compliance with the protocol, ICH GCP, applicable regulations and institutional SOPs. The CRA acts as the site’s primary contact with the trial sponsor.
- 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 trainings 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 Master Files in compliance with ICH guidelines
- Contribute to Clinical Development Standard Operating Procedures for conduct of clinical trials based on IAVI templates and ensures adherence to regulations/guidelines for GCP.
- Other duties as assigned.
EDUCATION AND WORK EXPERIENCE:
- Bachelor’s degree required, BS in scientific field, nursing degree or advanced degree in relevant field preferred
- Minimum 2 years relevant experience, including at least one year as a Clinical Research Associate, performing monitoring of clinical trials. 2+ years clinical monitoring experience preferred.
- Experience with clinical research data, investigational product, or maintenance of investigator site files.
- Experience with HIV or vaccine research preferred.
OTHER KNOWLEDGE, SKILLS, AND ABILITIES:
- 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
- Expert knowledge of Good Clinical Practices (GCP) and Good Documentation Practices
- Proficient in Microsoft Outlook, Word, Excel, PowerPoint
- Proficient in QA/QC systems and practices
- Knowledge of HIV and/or global health is preferred
- 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
Work Environment and Physical Demands:
The work environment and 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.
- Mobility to perform the essential functions of the position
- Hearing and speech sufficient to verbally communicate in person and on the telephone constantly (66-100%)
- Typical office environment
- Occasional travel off-site for team meetings with collaborators, as needed (up to 20%)
- Ability to travel to IAVI offices in New York
Perform other duties as assigned
IAVI Core Values
Dedication to the Mission: We are committed to the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world to achieve a world without AIDS
Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
Collaboration: We are committed to embracing diversity, the power of glocal teamwork and the belief that by working as one we can make a difference
- Leadership and Communication
- Proactively ask questions to understand organizational strategy and performance objectives
- Come up with new and unique ideas to achieve objectives
- Take proactive steps to collaborate with members from other teams/departments
- Seek solutions to a system/process failure
- Positively handle criticisms, complaints, and special requests
- Directly communicate with manager, peers and team members
Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.
All IAVI employees are expected to follow and abide by the legal, financial, regulatory, safety, and other general guidelines of IAVI, and to conduct their activities in a manner consistent with the highest personal and professional standards.
IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexu