Clinical Research Associate

8 hours ago

Pune Maharashtra, India Ascentrik Research Pvt Ltd Full time

**Job Type
- Fresher or Internship level**

Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe.

**Responsibilities**:
**1. Assist in Protocol Development**:

- Collaborate with the clinical research team to contribute to the development and review of clinical trial protocols.

**2. Site Identification and Selection**:

- Participate in the process of identifying and selecting clinical trial sites by conducting feasibility assessments.

**3. Regulatory Compliance**:

- Support the team in ensuring regulatory compliance throughout the clinical trial process.
- Assist in the preparation and submission of regulatory documents to appropriate health authorities.

**4. Site Initiation**:

- Assist in the initiation of clinical trial sites by coordinating site training activities and ensuring that all necessary documentation is in place.

**5. Monitoring and Data Collection**:

- Work closely with clinical research associates and investigators to monitor and collect data during the clinical trial.
- Assist in ensuring data accuracy, completeness, and adherence to protocol.

**6. Adverse Event Reporting**:

- Contribute to the process of monitoring and reporting adverse events, ensuring compliance with regulatory requirements.

**7. Study Close-Out**:

- Participate in the close-out activities of clinical trials, including the collection of essential documents and finalizing study reports.

**8. Collaboration and Communication**:

- Work collaboratively with cross-functional teams, including clinical operations, data management, and regulatory affairs.
- Communicate effectively with investigators, site staff, and study sponsors.

**9. Documentation and Record Keeping**:

- Maintain accurate and up-to-date documentation of all activities performed during the internship.
- Contribute to the development and organization of the trial master file.

**10. Learning and Development**:

- Actively engage in learning opportunities provided during the internship to enhance knowledge of clinical research processes and industry regulations.

**Qualifications**:

- Currently enrolled in a Bachelor's or Master's degree program in a related field (e.g., Life Sciences, Pharmacy, Nursing, etc.).
- Excellent communication and interpersonal skills.
- Detail-oriented with strong organizational and time management abilities.
- Ability to work independently and as part of a team.
- Fresher can also apply

**Salary**: ₹15,000.00 - ₹20,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Ability to Commute:

- Pune, Maharashtra (required)

Work Location: In person

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