Job Title: Senior Clinical Research Associate
Location: Mumbai/Chennai
Therapeutic Area Experience Required: Oncology/Immunology
Job Overview:
We are seeking a dedicated Senior Clinical Research Associate to perform monitoring and site management tasks for our clinical studies. The successful candidate will ensure that study sites adhere to protocols, applicable regulations, and sponsor requirements.
Key Responsibilities:
- Conduct site monitoring visits (selection, initiation, monitoring, and close-out) in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Collaborate with sites to implement and track subject recruitment plans, enhancing predictability and alignment with project needs.
- Provide protocol training and establish clear communication channels with sites to address ongoing project expectations and challenges.
- Assess the quality and integrity of site practices and escalate any issues as necessary.
- Monitor the progress of studies by tracking regulatory submissions, recruitment and enrollment, CRF completion, and data query resolution.
- Maintain proper documentation for the Trial Master File (TMF) and ensure compliance with GCP/ICH and local regulations.
- Generate regular visit reports, follow-up letters, and other necessary study documentation.
- Collaborate with team members for effective project execution.
- Support the development of site-specific subject recruitment plans and manage site financials per clinical trial agreements when applicable.
Qualifications:
- Bachelor’s degree in a scientific discipline or healthcare preferred; equivalent experience may be considered.
- Previous monitoring experience or completion of a CRA training program may be required by some organizations.
- Knowledge of clinical research regulatory requirements (GCP and ICH guidelines).
- Proficiency in Microsoft Word, Excel, and PowerPoint, as well as familiarity with using laptops and mobile devices.
- Strong written and verbal communication skills in English.
- Excellent organizational and problem-solving abilities.
- Effective time and financial management skills.
- Ability to build and maintain effective working relationships with colleagues, managers, and clients.
Why Join Us?
Join our dynamic team and contribute to groundbreaking research in oncology and immunology. We offer a supportive work environment and opportunities for professional growth.
How to Apply:
Interested candidates are invited to submit their resume and cover letter detailing their qualifications and experience.