CBCC Global Research is hiring for the role of Clinical Research Associate (CRA)/Senior CRA for our Bengaluru location. We are seeking professionals with 2-5 years of onsite monitoring experience in Patient-based Pharmacokinetic (PK) studies with a focus on oncology indications.
If you have a strong background in clinical research, site management, and therapeutic knowledge in oncology, this is an excellent opportunity to grow your career with a leading global research organization.
Key Responsibilities
As a CRA/Sr. CRA at CBCC Global Research, you will:
- Manage overall site operations for clinical trials and Patient-based PK studies.
- Ensure effective communication with clinical trial sites.
- Prepare for and conduct site visits.
- Assist the Project Manager (PM) in developing project plans.
- Prepare and manage the Site Activation Checklist.
- Handle back-office monitoring and centralized monitoring activities.
- Coordinate with sites to resolve Data Clarification Forms (DCFs).
- Perform other duties as assigned by the PM, Head-PM, and DO.
Pre-Requisite Skills
To be eligible for this role, you must have:
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- Minimum 2-5 years of onsite monitoring experience in clinical research.
- Hands-on experience in Patient-based PK studies with oncology indications.
- Strong knowledge of GCP guidelines, NDCT rules, COVID guidance, RECIST, and USFDA/EMA regulations.
- Expertise in handling ethics committee requirements and informed consent processes.
- Awareness of AE/SAE/deviations submission and documentation.
- Familiarity with phase trials, BA/BE studies, and trial-related setups.
- Experience in site selection, onsite/remote monitoring, and resolving patient recruitment challenges.
- Proficiency in EDC platforms and IP handling requirements.
Technical Expertise Required
- Therapeutic Knowledge: Strong understanding of oncology and related therapeutic areas.
- Regulatory Awareness: Up-to-date knowledge of global and local clinical trial regulations.
- Site Management: Ability to identify and manage good sites pan-India for specific indications.
- Problem-Solving Skills: Ability to address and overcome patient recruitment challenges.
Why Join CBCC Global Research?
- Work with a globally recognized clinical research organization.
- Opportunities to work on cutting-edge oncology studies.
- Collaborative and growth-oriented work environment.
- Competitive salary and benefits.
Eligibility Criteria
- Experience: 2-8 years in clinical research.
- Education: Relevant degree in Life Sciences, Pharmacy, or related fields.
- Location: Bengaluru, India.
- Note: Freshers are not eligible for this role.
How to Apply
If you meet the above criteria and are excited about this opportunity, please send your updated resume to career@cbcc.global
