Job Title: Clinical Research Associate I/II
Location: Bengaluru, Karnataka, India
Company: PSI CRO AG
Employment Type: Full-time, On-site
Industry: Pharmaceutical Manufacturing
Company Size: 1,001-5,000 employees
Application: Over 100 applicants
About Us:
PSI CRO AG is a dynamic and global company founded in 1995, uniting over 2,700 dedicated individuals. Our commitment extends to our staff, clients, partners, and the quality of our work. We strive to be at the forefront of medical science, impacting lives by bringing new medicines to those in need.
Job Description:
As a Clinical Research Associate I/II at PSI CRO AG, you will play a pivotal role in facilitating successful clinical research projects across various therapeutic areas. Your responsibilities will encompass effective communication with project stakeholders, maintaining relationships with clinical sites and investigators, ensuring subject safety and data compliance, and supporting regulatory activities.
Key Responsibilities:
- Conduct and report all types of on-site monitoring visits.
- Participate in study startup activities.
- Perform CRF (Case Report Form) review, source document verification, and query resolution.
- Manage site communication and act as the primary point of contact for in-house support services and vendors.
- Communicate study progress with internal project teams.
- Engage in feasibility research.
- Assist the regulatory team in preparing study submission documents.
Qualifications:
- Bachelor’s or master’s degree in Life Sciences (e.g., B.Pharm, M.Pharm, MSc, BSc, Pharm.D) or equivalent.
- 1-2 years of independent on-site monitoring experience in India.
- Experience with monitoring visits in Phase II and/or III clinical trials.
- Full proficiency in English.
- Proficiency in MS Office applications.
- Strong planning, multitasking, and teamwork abilities.
- Excellent communication, collaboration, and problem-solving skills.
- Willingness and ability to travel as needed.
Additional Information:
- Career Advancement: Opportunities for personal and professional growth in clinical research.
- Supportive Environment: Work closely with dedicated cross-functional teams and receive comprehensive support.
- Training & Development: Access extensive training programs and enjoy a collegial team atmosphere.
- Benefits: Competitive salary and benefits package.
- Working Conditions: Excellent working conditions with a focus on employee well-being.