The Lead Clinical Research Associate (US) will support conduct of clinical research within assigned clinical research centers that are actively participating in Nuvaira clinical trials and manage a small team of regional CRAs. As the Lead Clinical Research Associate (Lead CRA), you will act as the site manager for assigned clinical centers and will be responsible for developing positive relationships by providing clinical protocol training and support, study monitoring, clinical investigation awareness, recruitment assistance and continuing education for our emerging medical device. The Lead CRA will also be responsible for communicating internally any market dynamics, study issues or potential improvements, study activities/compliance, adverse event information and study enrollment strategies. As the Lead CRA, you will be responsible for daily management and task assignment of two-three regional CRAs. The Lead CRA will work closely with the study manager(s) to assist in overall trial conduction as appropriate.
- Act as the primary point of contact with assigned clinical study sites;
- Manage a small team of regional based CRAs
- Ensure sufficient site and procedure coverage by CRAs and guide CRAs with site issues
- Support study initiation, monitoring, audit and close out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
- Ensure clinical study site compliance according to GCPs, ICH and FDA regulations;
- Schedule, conduct and document Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits;
- Provide and document initial and ongoing study training (eg. protocol, EDC, etc.) to study site personnel;
- Ensure the protection of study subjects by verifying that the informed consent procedure and study protocol testing and procedures are performed appropriately and in alignment with the study protocol;
- Ensure the integrity of the clinical data submitted on eCRFs or other data collection tools by verifying against source documentation at the clinical study site;
- Ensure appropriate record-keeping at the clinical site, as well as the collection and submission of essential study documents to the study sponsor;
- Ensure appropriate investigational device storage and tracking at the clinical site;
- Independently identify and follow up on adverse events and other safety issues related to the clinical study, and ensure timely communication of serious adverse events to the Clinical Study Manager;
- Provide relevant, timely study subject updates to the Clinical Study Manager (eg. upcoming treatment dates, subject withdrawals, etc.);
- Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
- Collaborate with clinical study site and sponsor to trouble shoot and provide appropriate solutions to study-related issues, as appropriate;
- Work closely with clinical product training and proctoring teams;
- Assist in patient recruitment activities;
- Assist clinical study sites with audit preparedness;
- Assist with the development of study-related documents as requested;
- Prepare accurate and timely study visit reports as required by the study monitoring plan;
- Manage travel and expenses;
- Work independently and under general supervision.
- Bachelor’s degree (or higher) in nursing, health sciences or related field
- Minimum of three years of CRA experience with at least two years of clinical site monitoring;
- Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance;
- Respiratory disease trial experience preferred;
- Medical device trial experience preferred;
- Personnel management experience preferred;
- Strong oral and written communication skills;
- Proven organizational skills and the ability to manage multiple priorities
- Ability to travel approximately 50% with extensive travel during peak periods (up to 75%)
- Ability to manage personal expenses
- Strong computer skills
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.