Headquartered in Aventura, Florida, with regional offices and operations across North America and around the world, Biorasi is an award-winning fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies.
Biorasi hires talent and personality, not position holders. We’re a non-traditional work environment requiring only top performers. Every team member is a stock-holding owner and our culture reflects it.
This is a remarkable opportunity to dedicate yourself to become a vital part of a growing company in a thriving industry and benefiting professionally and financially from your accomplishments. If you have a passion for putting your knowledge and experience to test to achieve great outcomes in a client centric solution delivery setting, Biorasi wants to talk to you now. Responsibilities:
- Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plan; assist in developing and managing comprehensive Clinical study timelines and metrics; provides study-specific training and leadership to clinical research staff; prepares and presents project debriefings, as required; plans, executes, and leads study-specific meetings (e.g., Study Management Meetings, investigator meetings); participates in site monitoring visits as appropriate. Manages overall study recruitment campaigns and manages enrolment timelines
- Uses operational and therapeutic expertise to optimize trial design and execution: works with the study team to design clinical protocol; provides input for the design of the ICF template, Source documents and CRFs
- Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines). Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets).
- Responsible for ensuring that Project Team delivers timely and satisfactory Project and Client Clinical deliverables
- Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate
- Management of all Clinical Trial Assistants (CTAs) and Clinical Monitors, to include coaching and providing guidance; Mentor the CTAs on the subjects of job performance, trainings and professional growth
- Daily interaction with study Director, Clinical Services Branch and members of the cross-functional study team
- Selects sites and countries; develops relationships with investigators and site staff
- Lead the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, vendors, etc.)
- Lead and partake in regular team meeting / teleconferences; Participate/present at Client Presentation Meetings as necessary; Participate/present at Investigator Meetings as necessary
- Communicate any out of scope issues to upper management as soon as identified
- Other duties as assigned
Qualifications and Experience Required:
- Bachelor’s Degree in biomedical sciences or related scientific discipline
- 8+ years of clinical research experience
- Excellent verbal and written communication skills required
- Excellent organizational, multi-tasking and time management skills required
- Sound knowledge of medical terminology and clinical trial management process
- Excellent verbal and written communications skills
- Knowledge of FDA regulations and ICH guidelines
- Excellent skills at documenting study conduct and management
- Effective business skills for interactive situations with peers, sites and clients
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