Greetings of the day !
Our reputed MNC Client is hiring for CRA/ Senior CRA role:
Location: Sec- 94, Noida
Work Mode: WFO
Shift: General
NOTE: It is an individual contribution role.
Key Responsibilities
- Will develop the outline trial protocols and manage Investigational Product (IP) and trial materials.
- Will manage multiple aspects of subjects' welfare.
- project coordination with CROs, carry monitoring visit at CRO to manage study logistics.
- Will conduct regular site visits, generate, and distribute internal and external newsletters, prepare final reports and liaison with interested parties regarding all trial aspects.
- Identify, evaluate, and establish trial sites, and ensure the completion of trial.
- To train site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.
- Liaison with ethics committee regarding rights, safety, and well-being of trial subjects.
- Overseeing and documenting IP dispensing, inventory, and reconciliation.
- Protecting subjects confidentiality, updating their information, and verifying IP has been dispensed and administered according to the protocol.
- 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.
- Cooperative approach of working with Sales & Marketing team for initiating projects.
Warm Regards,
Gayatri Kumari
Email Id:
[email protected]
V3 Staffing Solutions
📌 Clinical Research Associate || Senior Clinical Research Associate (Uttar Pradesh)
🏢 V3 Staffing
📍 Uttar Pradesh