Job Description

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\xe2\x80\x99ve ever heard of.
Biorasi is looking for top performers who are as passionate about clinical research as we are \xe2\x80\x93 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- Manager, Clinical Operations!
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: Tasks related to CRA Oversight and Line Management

• Provide direct line management of Clinical Research Associates (CRAs)
• Mentor CRAs about job performance, training, and professional growth
• Develop and maintain CRA Oversight and Evaluation Program

• Ensure global framework for CRA Oversight is documented
• Track new hires or junior CRAs and ensure timely sign-off of oversight visits
• Oversee process for routine oversight of CRAs as part of ongoing due diligence
• Conduct an on-site or remote evaluation of CRAs
• Serve as escalation point for any performance issues and ensure training is completed and documented where appropriate
• Participate in career growth initiatives of Clinical Trial Associates into CRA position
• Assist project teams with resource allocation, reviewing site performance, providing feedback to CRAs, providing support in resolving issues.
• To lead and partake in regular team meetings/teleconferences
• Take part in clinical branch or company-wide process improvement initiatives
• Contribute to SOP review and updates as needed

Tasks related to Clinical Trial Management

• May administer protocol and study training to internal project team and establishes regular lines of communication to manage ongoing project expectations and issues
• Lead review and approval of site visit reports
• May occasionally schedule, plan, and conduct site visits, as needed: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-out Visits
• Study Start-up: Support as CTM in contributing to the list of approved sites for selection visits, site initiation, including submitting documents to the IRB, preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines, study logs, and forms).
• Site Management: Support as CTM in the tracking of subject recruitment at all study sites. Track study/site performance on an ongoing basis and escalate any infringements, breaches, and misconduct, fraud, and trends at sites. Ongoing protocol deviation tracking, reporting, and trending. Assist in communication to sites.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Assist the project team in the resolution of audit findings; assist the project team in review and maintenance of clinical trial documentation for audit readiness.

• Bachelor\xe2\x80\x99s or post graduate degree in Pharmacy, biomedical or related scientific discipline
• Fluent in English (oral and written) and applicable local business language.
• Minimum 10 years of clinical research experience with a combination of clinical monitoring, study operations, and other relevant clinical research experience
• Ability to travel up to 15% depending on project needs
• Good knowledge of medical terminology and expert proficiency level in clinical trial monitoring and management process.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• Effective business skills for interactive situations with peers, sites, and clients.
• Extremely good team player
• Passionate about the role and willing to work at ground level if need be.
• Commitment to Quality and development of staff.

About Our Company
If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com.
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 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.