Location: Mumbai
Experience Required: 1–2 Years
Salary: ₹4.5–6 Lacs per Year
Qualifications: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Biorasi, a full-service Clinical Research Organization (CRO), is renowned for its innovation, collaboration, and dedication to advancing life-changing therapies. We are growing and looking for passionate individuals to join our dynamic team and make a difference in clinical research. Biorasi Hiring for Clinical Project Associate
About the Role
The Clinical Project Associate will play a key role in supporting clinical trial operations, ensuring smooth execution of clinical studies. This position involves managing site operations, coordinating with vendors, and ensuring compliance with international GCP guidelines.
Key Responsibilities
Communication
- Participate in meetings and teleconferences.
- Develop and share agendas, minutes, and monthly status reports.
- Track and document project updates and action items for stakeholders.
Site Management
- Assist with site budget development, contract preparation, and payment administration.
- Support Clinical Trial Managers (CTMs) in subject recruitment tracking and monitoring visit schedules.
Study Start-Up and Activation
- Assist in developing project plans for site feasibility, selection, and activation.
- Coordinate and review regulatory documentation for site initiation.
Document and Supplies Management
- Collect, file, and archive essential documents in the Trial Master File.
- Oversee the distribution and tracking of study supplies.
Study and Vendor Management
- Maintain project trackers and systems like CTMS and study portals.
- Support vendor identification, selection, management, and payment processing.
Compliance and Support
- Ensure adherence to ICH GCP guidelines and local regulations.
- Assist in resolving audit findings and preparing for audit readiness.
Your Profile
Qualifications
- Associate’s or Bachelor’s degree in biomedical sciences or a related field.
- Prior clinical research experience, preferably as a study coordinator or regulatory coordinator.
Skills and Knowledge
- Basic understanding of ICH GCP and global/local regulatory requirements.
- Proficiency in MS Office tools like Word, PowerPoint, and Excel.
- Strong written and oral communication skills in English.
Desired Attributes
- Detail-oriented with excellent organizational skills.
- Ability to manage multiple tasks while meeting deadlines.
Benefits
- Work/Life Balance: Half-day Fridays, paid time off, and holidays.
- Professional Growth: Employee bonus programs and career development opportunities.
- Training: Ongoing training and development sessions.
- Perks: Extensive country-specific benefits.
Why Join Biorasi?
At Biorasi, we offer a collaborative environment where you can grow professionally while contributing to groundbreaking clinical research projects.
Apply Now to join a team committed to innovation and making a difference in patient lives.
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