Biorasi is a full-service Clinical Research Organization (CRO) known for innovation, collaboration, and commitment to bringing life-changing therapies to patients. We are growing and inviting passionate individuals to join our dynamic team and contribute to advancing clinical research.
About the Role:
The Clinical Project Associate position involves supporting clinical trial operations across various facets, from site management to vendor coordination. This role is pivotal in ensuring the smooth execution of clinical studies while maintaining compliance with international GCP guidelines and regulations.
Key Responsibilities:
Communication:
- Participate in meetings and teleconferences.
- Develop and circulate agendas, minutes, and monthly status reports.
- Track and document key 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 & Activation:
- Support in developing project plans for site feasibility, selection, and activation.
- Coordinate regulatory documentation retrieval and review for site initiation.
Document & Supplies Management:
- Manage essential document collection, filing, and archival in the Trial Master File.
- Oversee the logistics of study supplies, ensuring proper distribution and tracking.
Study & Vendor Management:
- Maintain project trackers and systems like CTMS and study portals.
- Assist in vendor identification, selection, management, and payment administration.
Compliance & Support:
- Ensure adherence to ICH GCP guidelines, local regulations, and company SOPs.
- Support the resolution of audit findings and preparation for audit readiness.
Your Profile:
Qualifications:
- Associate’s or Bachelor’s degree in biomedical sciences or related field.
- Prior clinical research experience is required, with study coordinator or regulatory coordinator experience preferred.
Skills & Knowledge:
- Basic understanding of ICH GCP and global/local regulatory requirements.
- Proficiency in MS Office (Word, PowerPoint, Excel).
- Strong communication skills in English (oral and written).
Desired Attributes:
- Detail-oriented with excellent organizational skills.
- Ability to manage multiple tasks while adhering to timelines.
Benefits:
- Half-day Fridays, paid time off, and holidays.
- Extensive country-specific benefits.
- Employee bonus programs and career growth opportunities.
- Ongoing training and development.
