Clinical Research Coordinator

3 months ago

Bengaluru, India Clini launch Research Institute Full time

**Job Summary**:
**Responsibilities**:
**Protocol Development**:
Collaborate in the development of clinical trial protocols, ensuring alignment with regulatory requirements and study objectives.
Provide input into the design of study documents, such as Case Report Forms (CRFs) and Informed Consent Forms (ICFs).

**Site Selection and Monitoring**:
Conduct pre-study site evaluations and initiate investigator sites.
Monitor clinical sites to ensure protocol adherence, data accuracy, and regulatory compliance.
Provide training and support to site staff as needed.

**Regulatory Compliance**:
Ensure compliance with applicable regulatory standards, ICH-GCP guidelines, and company SOPs.
Assist in preparing and submitting regulatory documents for ethics committee and regulatory authority approval.

**Data Management**:Oversee data collection, review, and resolution of discrepancies.
Ensure the completeness, accuracy, and quality of clinical trial data.

**Safety Reporting**:
Manage and report serious adverse events (SAEs) in compliance with regulatory requirements.
Collaborate with the Safety Department to ensure timely reporting and resolution of safety issues.

**Study Close-Out**:
Coordinate and conduct site close-out activities.
Ensure proper archiving of study documents in accordance with regulatory standards.

**Qualifications**:

- Bachelor's or higher degree in life sciences or a related field.
- Previous experience as a Clinical Research Associate or in a similar role.
- Strong understanding of clinical trial processes and regulatory requirements.
- Excellent organizational and communication skills.
- Ability to work independently and collaboratively in a team environment.
- Proficiency in Microsoft Office and familiarity with electronic data capture systems.

**Certifications**:Relevant certifications (e.g., SoCRA, ACRP) are a plus.

**Job Types**: Full-time, Permanent, Fresher

**Salary**: Up to ₹30,363.97 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- Bangalore, Karnataka (required)

Ability to Relocate:

- Bangalore, Karnataka: Relocate before starting work (required)

**Speak with the employer**
+91 7676759293

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