Overview
The Clinical Research Associate II (CRA) will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring, site and vendor management. The CRA II will work cross functionally within the Rezolute team as well as with study sites, CROs and other vendors.
Principle Duties and Responsibilities Include:
- Prepare regulatory binders, study manuals including review of the monitoring plan, central lab manuals,
- Assist with ensuring local insurance is in place for each participating country
- Work with the CROs to ensure import/export licenses are in place to support the study
- Oversee or participate in qualification visits, site initiation visits, monitoring visits and close out visits
- Build productive and collaborative relationships with cross-functional teams
- Oversee identification, follow up and resolution of site, vendor, or study level issues
- Review and provide oversight of the electronic Trial Master File and ensure vendor participation, as needed
- Contribute to clinical project team meetings and (as needed) provide agendas and minutes
- Develop and maintain study trackers and track clinical supply inventory
- Protect patients: Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol
- Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)
- Evaluate the quality and integrity of the reported data, site efficacy and drug accountability
- Monitor the completeness and quality of Regulatory Documentation and perform site document verification as needed
- Escalate matters as required to appropriate team individuals
Qualifications/Requirements:
- Bachelor’s degree in a relevant scientific discipline or equivalent
- At least 4 years of relevant work experience
- Knowledge of GCP and ICH guidelines preferred
- Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
- Ability to perform all clinical monitoring activities and work independently with minimal assistance
- A client-focused approach to work and flexible attitude with respect to assignments/new learning
- Good organizational skills with the ability to manage multiple tasks, adapt to changing priorities and evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s)
- Strong computer skills, including but not limited to the knowledge of electronic clinical databases such as RAVE and/or similar platforms, a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel, Word, Outlook, and PowerPoint
- Excellent demonstrated verbal and written communication skills
- Able to work within a team and is a good team player
- Must be willing to travel (15-20%)
Preferred Experience, Special Skills and Knowledge: We are looking for a candidate that is highly motivated, able to pivot as programs evolved, come into the office at least 2 days a week, can pick up tasks quickly and will help contribute to the constant needs and demands of the clinical operations team.
