CLINICAL TRIAL EXECUTIVE INTERN
Site selection and qualification
Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, if required train the study site team
Ensures dossier submission at sites, approval and site initiation visit
Ensuring targeted recruitment
Monitor study progress to assure compliance with protocol requirements, applicable regulations, guidelines, and Good Clinical Practices
Monitor and track patient enrollment and study progress
Perform site monitoring visit / remote monitoring visit to include a review of the source document, case report form, ICD, Patient Diary, Investigator Site Binder other documents as applicable
Ensure collection of all data and remaining study supplies for return to the Sponsor
Prepare the site for possible Internal and/or Client Audits / Inspections
Archival with Inventory list of Source documents/ CRFs/ CTM/ Others at site
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
Schedule
Morning shift
Ability to commute/relocate
Kochi, Kerala
- Job Type
- Fresher
- Pay
- ₹10,000.00 - ₹15,000.00 per month
Education
Bachelor's (Preferred)
- Work Location
- In person
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