Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Summarized Purpose:

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or in office visits to assess protocol and regulatory compliance and manages required
documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial
is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops
team-oriented relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix

Essential Functions
Monitors investigator sites using a risk-based monitoring approach.
Applies root cause analysis (RCA), critical thinking, and problem-solving skills to:
Identify site process failures.




Determine corrective and preventive actions.
Bring sites into compliance.
Reduce study and site-level risks.
Ensures data accuracy through:
Source Data Review (SDR).
Source Data Verification (SDV).
Case Report Form (CRF) review, as applicable.
In office and remote monitoring activities.
Assesses investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner using approved business writing standards.
Escalates observed deficiencies and issues to clinical management promptly and follows issues through to resolution.
Maintains regular contact between monitoring visits with investigative sites, as needed, to confirm:
Protocol compliance.
Resolution of previously identified issues.
Timely recording of study data.
Conducts monitoring activities in accordance with the approved monitoring plan.
Participates in the investigator payme

📌 Cra I Mumbai
🏢 Thermo Fisher Scientific
📍 Mumbai