Clinical Research Executive/Associate

QPS Bioserve; Hyderabad; On-site; INR 500,000 - 850,000; Full time

Job summary

QPS Bioserve in Hyderabad, India is seeking a Clinical Study Coordinator to coordinate and oversee BA/BE clinical studies in line with GCP, regulatory requirements, SOPs, and Ethics Committee guidelines. You will focus on volunteer safety, protocol adherence, and meticulous documentation to ensure study reliability.

Responsibilities include ensuring materials and essential documents are ready before initiation, maintaining TMF and trial records, preparing for regulatory inspections, and

Qualifications

• Oversee BA/BE clinical studies following GCP and SOPs.
• Ensure regulatory documents and ethics approvals are in place.
• Maintain accurate trial documentation and records.
• Coordinate study materials and essential documents before initiation.

Responsibilities

• Coordinate and oversee the conduct of BA/BE clinical studies as per protocol and regulatory requirements.
• Ensure regulatory documents are available in the Trial Master File.
• Prepare readiness of the clinical unit, emergency unit and equipment.
• Verify informed consent prior to procedures and coordinate check-in/check-out.
• Ensure protocol procedures follow the schedule and SOPs.
• Train subjects on do's and don'ts during the study.
• Coordinate with investigators for drug administration and sample collection.
• Monitor dosing and post-dose activities; report adverse events to investigators.
• Review source documents and CRFs for completeness; reconcile study documentation.

Skills

GCP compliance

Regulatory knowledge

Study coordination

Documentation

Ethics compliance

SOP adherence

Tools

TMF management

Job description

Role & responsibilities:

• To coordinate and oversee the conduct of BA/BE clinical studies in accordance with study protocols, Good Clinical Practice (GCP), applicable regulatory requirements, SOPs, and Ethics Committee requirements while ensuring volunteer safety, protocol compliance, and accurate documentation.
• Ensure study materials and essential documents are available before study initiation.
• Ensures that regulatory related documents, approved Protocol and Informed consent forms etc., are available with the Trial Master File.
• Ensures readiness of the clinical unit, emergency unit and equipments for conduction of the study activities.
• Arrange of all study related documents as per the protocol requirements.
• Verify informed consent has been obtained before any study procedures.
• Coordinate check-in and check-out activities.
• Ensure protocol procedures are performed according to the schedule.
• Training the subjects on do s and donts during the study
• Coordinate with investigator and coordinators for drug administration activity
• Coordinate with the clinical staff for drug administration, sample collection, vitals checking and processing etc., for performing according to the protocol.
• Ensure correct dosing and monitor post-dose activities.
• Reporting of adverse events to investigator / physician for adverse event management
• Coordinate with the dietician for standardized diet distribution as per the study protocol .
• Review source documents and CRFs for completeness.
• Reconcile study documentation.
• All other internal activities as assigned by Department head and Team lead.