About the Opportunity
This opportunity is for one of the fastest-growing pharmaceutical companies in the country that is in need of a Sr. Regional Clinical Research Associate to join their team located in the Northeast region. This position offers an extremely competitive compensation package and significant potential to advance internally, as they are continuing to grow, but strive to keep the smaller company feel.
The annual base salary range is $100,000 to $140,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
- Interact with personnel from study Sponsors, investigational sites, vendors, and other functional groups to enable quality and on-time execution of clinical trials
- Identify potential sites for participation in clinical trials
- Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites
- Participate in Investigator Meetings, CRA and Study Coordinator training sessions, and assist sites with study-related questions as needed
- Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed
- Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan
- Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS). Completion of monitoring visit reports and follow-up letters includes summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance
- Assist with precept/oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their manager/Associate Director
- Bachelor’s degree in a life science or related field of study
- Minimum of 4-5+ years of monitoring experience
- Located near a major hub airport