Clinical Research Associate
7 months ago
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.
**Clinical Research Associate 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, and ability to manage travel schedules, such as flight schedules.
- Valid driver’s license, proficient driving skills, own reliable transport, and up-to-date car insurance.
Pay: ₹12,059.69 - ₹28,802.03 per month
**Benefits**:
- Internet reimbursement
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
Ability to commute/relocate:
- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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