Senior Clinical Research Associate

**We are Growing**

Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of.

Biorasi is looking for top performers who are as passionate about clinical research as we are - clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

**Start your career journey at Biorasi today with our newest opportunity
- **Senior** **Clinical Research Associate (CRA) This is a remote based position located anywhere within France.**

**Overview**
- We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India, Russia, and Ukraine.
- Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
- Development and worklife balance: We want our employees to develop personally as well as professionally

**Your Responsibilities**:

- Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits
- Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits
- Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission
- Provide project updates to project management team
- Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites
- Perform investigational product inventory and ensure return of unused investigational product Assists with, prepare for, and attends Investigator Meetings
- Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents
- Collect and review essential study documents from site for filing in eTMF
- Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites
- Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations
- Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies
- Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs
- May review protocols, eCRFs, study manuals and other study related documents
- May conduct on-site evaluation visits and on-site training of CRAs
- Lead and partake in regular team meeting
- Assist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance
- Bachelor’s Degree in biomedical sciences or related scientific discipline
- Fluent English (oral and written) and applicable local business language
- Minimum three years of monitoring experience
- Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process
- Ability to travel up to 70%, depending on project requirements
- Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
- Excellent verbal, written communication and presentation skills
- Good leadership, planning, project management skills, verbal communication skills, and written communication skills
- Knowledge and experience with MS Office suite

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.