Biorasi is an award-winning, full-service clinical research organization recognized for its innovative, collaborative, and dynamic approach. With a customer-focused ethos, Biorasi is at the forefront of clinical trial services, supporting clients across the globe. Our aim is to empower professionals by providing growth opportunities and maintaining a healthy work-life balance, while driving the development of new therapies to improve patient lives.
Responsibilities in the Job: What You’ll Do as a CRA/Senior CRA
As a CRA or Senior CRA at Biorasi, you will take on key responsibilities, including but not limited to:
- Scheduling and Conducting Site Visits: Conduct comprehensive site selection, initiation, interim monitoring, and close-out visits.
- Documenting Reports: Write detailed site visit reports and follow-up letters for various site visits.
- Monitoring Study Progress: Track regulatory/IRB submissions and approvals, recruitment and enrollment metrics, CRF completion, and data query resolution.
- Project Coordination: Provide regular project updates to the project management team.
- Organizing Study Materials: Coordinate the delivery and return of investigational products, laboratory supplies, and other essential materials.
- Compliance and Safety Oversight: Review study documents to ensure adherence to ICH GCP guidelines, protocol compliance, and safety event monitoring.
- Training and Communication: Administer study training to sites and establish consistent communication.
- Audit and Quality Assurance: Participate in planning quality assurance activities and assist in resolving audit findings.
- Leadership and Support: Serve as a mentor to junior team members, review reports, and contribute to team meetings.
Qualifications: What We’re Looking for in Candidates
To excel in this role, candidates should meet the following qualifications:
- Educational Background: Bachelor’s degree in biomedical sciences or a related scientific field.
- Experience: Minimum of 2-3 years of monitoring experience, with a preference for more extensive experience. Prior roles as a clinical research coordinator or related positions are a plus.
- Regulatory Knowledge: Strong understanding of ICH GCP guidelines and worldwide regulatory requirements.
- Communication Skills: Excellent verbal and written English skills; fluency in the local business language is also essential.
- Technical Proficiency: Competency in MS Office Suite (Word, PowerPoint, Excel).
Skills: What Sets You Apart
To thrive at Biorasi, you should possess the following skills:
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- Leadership and Planning: Capable of guiding and mentoring peers, with strong planning and project management abilities.
- Analytical and Problem-Solving: Skilled in evaluating site practices, ensuring compliance, and resolving challenges.
- Interpersonal Skills: Effective business acumen for interacting with clients, peers, and sites.
- Presentation and Training: Confident in conducting training sessions and presenting updates to stakeholders.
