Clinical Research Associate Intern

2 weeks ago

Kochi, India Clinovex Clinical Research Solutions Pvt Ltd. Full time

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

**Experience**:

- total work: Freshers -1 year (preferred)

**Job Types**: Full-time, Part-time, Fresher, Internship

**Salary**: ₹10,250.39 - ₹37,501.74 per month

Ability to commute/relocate:

- Kochi, Kerala: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

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