Clinical Trials Assistant

6 months ago

Pune, India Pitre Business Ventures LLP Full time

The Clinical Trial Assistant (CTA) will provide administrative and operational support to the leadership team, clinical research coordinators and Principal investigators accross company's portfolio of clinical trials from startup execution and close out.

**Key Responsibilities**:
**Regulatory**:
1. Ensure that all study records, including participant files and essential documents are maintained accurately and securely.

2. Prepare and submit regulatory documents for study approvals.

**Data Entry**:
1. Enter clinical trial data into electronic databases or data management systems accurately and promptly.

2. Validate data entries against source documents, including case report forms (CRFs) and medical records to ensure alignment

**Electornic Medical Record (EMR) Mining**:
1. Perform Data mining tasks in multiple EMR Partner systems to identify potential patients based on trial inclusion/ exclusion criteria and medical records match with on-sight or remote EMR access.

2. Process Potential volunteers (chart review, in person, phone) and document accordingly, database proficiency, capture and report detailed medical history and medication list and assess patient eligibility based on protocol inclusion and exclusion criteria.

**Reporting**:
Generate weekly reports from Clinical Trial Management System to monitor study enrollment and source of business.

**Perform other administrative and operational tasks as needed.**

**Qualifications**:

- Prior medical training or education required.
- Must possess strong organizational skills and attention to detail.
- Previous experience in Clincial research is preferred.
- Experience with electronic medical records systems (EMR/ EHR), medical conditions and medications is preferred.
- Well-developed written and verbal communication skills (English)
- Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
- Ability to be professional, respectful of others, self motivated and exemplify a strong work ethic.
- Must possess a high degree of integrity and dependability.
- Ability to work under minimial supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner and in compliance with HIPAA guidelines.

Pay: From ₹18,000.00 per month

Schedule:

- Day shift

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- Pune, Maharashtra (required)

Ability to Relocate:

- Pune, Maharashtra: Relocate before starting work (required)

Work Location: In person

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