Job Description

RESPONSIBILITIES

• Complete appropriate role-specific training to perform job duties
• Under supervision, perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.)
• Under supervision, assist in updating and maintaining systems within project timelines and per project plans
• Maintaining the source documents, CRF's, Investigator Site File and other study related documents according to ICH-GCP guideline
• Completing the eCRF
• Maintenance of Investigational Product according to the specific temperature.
• Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits.
• Organizing ethics committee meetings
• Completing the review forms and submitting all study related documents to EC
• Coordinating with the local labs, central labs
• Assistance in Safety Reporting within the required timelines.
• Assistance in patient selection and recruitment
• Assistance in Informed Consent Process

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Basic knowledge of applicable research and regulatory requirements, i.e., ICH GCP and relevant local laws,

regulations and guidelines

• Exposure to MS Applications including but not limited to Microsoft Word, Excel and PowerPoint
• Effective written and verbal communication skills including good command of English language
• Effective time management skills
• Results and detail-oriented approach to work delivery and output
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Strong listening and phone skills
• Good data entry skills

Required Experience, Skills and Qualifications

MSc Biotechnology, Microbiology, Biochemistry B. Pharm, M. Pharm, Pharm D. MSc. Bsc. LifeScience: Bioinformatics, Biomedical Engineering ect.Job Types: Full-time, Internship

Job Type: Full-time

Salary: ?211,274.00 - ?456,705.00 per year

Schedule:

• Morning shift

Ability to commute/relocate:

• Kochi, Kerala

Experience:

• total work: Freshers -1 year (Preferred)

Job Types: Fresher, Internship

Pay: ?15,250.39 - ?25,000.00 per month

Education:

• Master's (Preferred)

Work Location: In person