Work from home Oppurtunity as Clinical Research Associate at Biorasi

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:

• 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.

Application Link