Biorasi is an award-winning Clinical Research Organization (CRO) known for its innovative and collaborative work culture. It supports cutting-edge clinical trials and is committed to improving healthcare outcomes globally. With a focus on work-life balance, Biorasi encourages professional development while fostering employee well-being.
Key Responsibilities of the Senior Clinical Research Associate
As a Senior CRA, your primary duties will involve site monitoring, compliance, and project management to ensure the success of clinical studies. Here’s a closer look at your responsibilities:
- Site Visits Management:
- Schedule and conduct site selection, initiation, interim monitoring, and close-out visits.
- Document the process through reports and follow-up letters.
- Site Management Activities:
- Provide project updates to internal teams and ensure regulatory submissions are complete.
- Oversee delivery of investigational products, CRFs, and laboratory packs.
- Ensure compliance with study protocols, ICH GCP guidelines, and FDA regulations.
- Monitor safety events and escalate issues at clinical sites to project management as needed.
- Compliance and Quality Assurance:
- Ensure clinical studies align with Good Clinical Practices (GCP) and other international regulations.
- Participate in quality assurance activities and address audit findings.
- Team Leadership and Mentoring:
- Mentor junior associates on job performance, training, and career development.
- Lead or participate in regular team meetings and teleconferences.
Qualifications for the Senior Clinical Research Associate Role
To succeed in this role, candidates need to meet the following criteria:
- Educational Requirements:
- Bachelor’s degree in biomedical sciences or a related scientific discipline.
- Professional Experience:
- 2-3 years of monitoring experience; additional clinical research or project coordination experience is preferred.
Skills Needed for Success
Biorasi is looking for candidates with the following abilities and competencies:
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- Knowledge: Familiarity with medical terminology, clinical research processes, and ICH GCP guidelines.
- Leadership and Project Management Skills: Proven ability to lead and manage projects effectively.
- Communication Skills: Strong verbal and written communication abilities to collaborate with internal teams and stakeholders.
- Travel Readiness: Willingness to travel regionally up to 70%, based on project needs.
Application Link Official Portal
