Join Biorasi – A Thriving Clinical Research Organization
Company Introduction
Biorasi is a rapidly growing, award-winning, customer-focused clinical research organization (CRO). Known for innovation, collaboration, and dynamic work culture, Biorasi aims to support clinical trials and bring new therapies to patients. Whether you’re a seasoned clinical trial veteran or a newcomer eager to make an impact, Biorasi is the ideal place to grow your career in the expanding clinical research industry.
Key Responsibilities of a CRA/Senior Clinical Research Associate
As a CRA or Senior CRA, you will play a pivotal role in managing clinical trial sites, ensuring that all aspects of the trials are conducted according to protocol and regulatory standards. Your main responsibilities include:
- Site Visits: Plan, schedule, and conduct Site Selection, Initiation, Interim Monitoring, and Close-out Visits.
- Documentation: Write reports and follow-up letters for all site visits, ensuring proper record-keeping for compliance.
- Study Management: Track regulatory submissions, monitor recruitment and enrollment, ensure data accuracy, and resolve data queries.
- Project Coordination: Provide regular updates to the project management team and oversee the delivery of study materials to clinical sites.
- Compliance: Ensure adherence to ICH GCP guidelines, protocol, and site practices, and escalate any issues that may affect subject safety or data integrity.
- Site Communication: Establish regular contact with sites to provide training and manage expectations for ongoing projects.
- Investigational Product Management: Oversee investigational product inventory and coordinate its return or destruction as required.
- Quality Assurance: Participate in quality assurance activities and audit resolution.
- Mentorship: Provide guidance and mentorship to junior CRAs and other clinical team members, as needed.
- Team Meetings: Lead or participate in regular team meetings and contribute to overall study performance analysis.
Qualifications and Skills Required
To succeed in this role, you should possess the following qualifications:
- Educational Background: A Bachelor’s Degree in biomedical sciences or a related scientific discipline.
- Clinical Research Experience: Minimum of 2-3 years of monitoring experience, with additional clinical research experience preferred.
- Knowledge: Strong understanding of medical terminologies, clinical monitoring processes, and ICH GCP guidelines.
- Language Skills: Fluent in English, both oral and written. Proficiency in local business languages is also essential.
- Technical Skills: Proficiency with MS Office Suite (Word, PowerPoint, Excel) and familiarity with eTMF systems.
- Leadership & Communication: Strong verbal, written communication, and presentation skills, along with leadership and project management abilities.
- Regulatory Knowledge: Comprehensive understanding of global regulatory requirements and clinical research guidelines.
