Clinical Research Associate 2+ Years

2 days ago

Pune, India Nuntiare Promotions Pvt Ltd Full time

**We are looking for an organized, flexible clinical research associate to oversee clinical trials.**

The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials.

**Responsibilities**:

- Creating and writing trial protocols, and presenting these to the steering committee.
- Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
- Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
- Ordering, tracking, and managing IP and trial materials.
- Overseeing and documenting IP dispensing inventory, and reconciliation.
- Conducting regular site visits, coordinating project meetings, and writing visit reports.
- Implementing action plans for sites not meeting expectations.
- Liaising with regulatory authorities.
- Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
- Other tasks and responsibilities as needed.

**Requirements**:

- Bachelor’s degree in biological science or a related field.
- 2+ years of experience as a clinical research associate.
- Knowledge of the pharmaceutical industry, terminology, and practices.
- Knowledge of FDA regulations and their practical implementation.
- Strong verbal and written communication skills.
- Proficient computer skills.
- Proficient with Microsoft Office Word, Excel, and PowerPoint.
- Ability to manage and prioritize workload effectively.
- Available to travel extensively and on short notice.

Pay: ₹20,000.00 - ₹30,000.00 per month

Schedule:

- Day shift

Ability to commute/relocate:

- Pune, Pune - 411045, Maharashtra: Reliably commute or planning to relocate before starting work (preferred)

**Experience**:

- total work: 1 year (preferred)

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