Thermo Fisher Scientific is hiring for the position of Clinical Research Associate I – FSP (CRA I – FSP) in Mumbai, India. The role is listed as Fully Remote and offers an opportunity for clinical research professionals with independent onsite clinical monitoring experience to work across clinical trials in India.

The CRA I – FSP position focuses on clinical trial monitoring, site management, ICH-GCP compliance, source data review (SDR), source data verification (SDV), regulatory documentation, risk-based monitoring, site issue resolution, and audit readiness.

Candidates with a Master’s degree in a life sciences-related field, preferably Pharmacy, and 1–2 years of independent onsite clinical monitoring experience may be eligible for this opportunity. Experience monitoring oncology clinical trials is preferred.

Thermo Fisher Scientific CRA I – FSP Job Details

About the CRA I – FSP Role

The Clinical Research Associate I – FSP will perform and coordinate clinical monitoring and site management activities for clinical trials. The CRA will work with investigative sites, sponsors, and internal project teams to ensure that clinical trials are conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations, and standard operating procedures (SOPs).

The position involves both remote and onsite monitoring activities, including reviewing clinical trial documentation, assessing site compliance, identifying risks, following up on findings, and maintaining study information in clinical trial systems.

A major part of the role involves ensuring subject rights and well-being, data reliability, protocol compliance, and inspection and audit readiness.

Thermo Fisher CRA I – FSP Responsibilities

Selected candidates may be responsible for the following clinical research and site management activities:

• Conduct investigator site monitoring using a risk-based monitoring (RBM) approach.
• Perform onsite and remote clinical monitoring activities according to the approved monitoring plan.
• Conduct Source Data Review (SDR) and Source Data Verification (SDV).
• Review Case Report Forms (CRFs), where applicable.
• Assess investigational product inventory and related records.
• Identify site process failures and clinical trial risks.
• Apply Root Cause Analysis (RCA) to investigate site issues.
• Recommend and follow up on corrective and preventive actions (CAPA).
• Support sites in achieving and maintaining protocol compliance.
• Document monitoring observations in monitoring reports and letters.
• Escalate significant deficiencies and issues to clinical management.
• Follow up on outstanding findings until appropriate resolution.
• Maintain regular communication with investigative sites between monitoring visits.
• Verify timely recording and reporting of study data.
• Conduct site initiation activities according to study and regulatory requirements.
• Perform clinical trial close-out activities and retrieve required trial materials.
• Review essential documents for completeness and compliance.
• Conduct onsite file reviews according to project specifications.
• Maintain clinical trial information and tracking in Clinical Trial Management Systems (CTMS).
• Provide study status and progress updates to project teams.
• Support investigator payment processes.
• Participate in investigator meetings when required.
• Assist with identifying potential investigators and qualified clinical trial sites.
• Facilitate communication between investigative sites, clients, and internal project teams.
• Respond to sponsor, company, regulatory, audit, and inspection requirements.
• Complete administrative activities such as timesheets and expense reports.
• Contribute to project tools, publications, and process-improvement initiatives.

Eligibility Criteria

Educational Qualification

Candidates should have a Master’s degree in a life sciences-related field, with Pharmacy being the preferred background.

Relevant educational backgrounds may include:

• M.Pharm
• Pharm.D / advanced pharmacy-related qualifications where the experience requirement is met
• Master’s degree in Life Sciences
• Other relevant life-sciences postgraduate qualifications

However, candidates should carefully verify their eligibility against the employer’s specific requirements before applying.

Clinical Research Experience

The position specifically requires:

• 1–2 years of independent onsite clinical monitoring experience
• Hands-on experience conducting clinical trial site visits across India
• Practical knowledge of clinical site management and monitoring activities

Oncology clinical trial monitoring experience is preferred.

Skills Required for CRA I – FSP

Candidates should have knowledge and skills in:

• Clinical trial monitoring
• ICH-GCP
• Risk-Based Monitoring (RBM)
• Source Data Verification
• Source Data Review
• Clinical Research
• Clinical Trial Management
• Site Management
• Protocol Compliance
• Regulatory Compliance
• Essential Documents
• CTMS
• Root Cause Analysis
• Corrective and Preventive Actions
• Medical terminology
• Therapeutic-area knowledge
• Clinical trial documentation
• Audit and inspection readiness
• Microsoft Office
• Written and verbal communication
• Stakeholder management
• Problem solving
• Critical thinking
• Time management
• Attention to detail

Knowledge of ICH-GCP and Regulatory Requirements

The CRA I – FSP is expected to maintain working knowledge of ICH-GCP requirements, applicable regulations, procedural documents, and clinical trial processes.

The role requires the CRA to ensure that investigative sites conduct trials according to the approved protocol and applicable requirements while protecting participant rights, safety, and well-being and maintaining the reliability of clinical trial data.

Risk-Based Monitoring Experience

Risk-Based Monitoring (RBM) is an important component of this position.

The CRA may be required to identify critical risks at investigative sites, investigate process failures, determine root causes, recommend corrective actions, and monitor the resolution of findings.

Candidates preparing for a CRA interview should therefore be familiar with concepts such as:

• Critical data and critical processes
• Risk identification
• Risk assessment
• Risk mitigation
• Centralized monitoring
• Remote monitoring
• Onsite monitoring
• SDV and SDR
• Query management
• Protocol deviations
• CAPA
• Root Cause Analysis

Work Location and Travel

The position is listed with a Fully Remote work arrangement and Mumbai, India as the location.

However, candidates should note that the job description states that the travel requirement may exceed 75%. Therefore, applicants should be prepared for substantial travel to investigative sites across India despite the remote classification.

Benefits and Career Opportunity

The supplied job description does not provide specific information regarding salary, bonuses, insurance, paid leave, or other employee benefits. Candidates should refer to the official Thermo Fisher Scientific job posting and employment documentation for the applicable compensation and benefits package.

From a role perspective, the position provides exposure to areas including:

• Clinical trial monitoring
• Investigator site management
• Risk-based monitoring
• Oncology clinical research
• ICH-GCP
• Regulatory compliance
• Clinical trial documentation
• CTMS
• Sponsor and site communication
• Audit and inspection readiness

Who Can Apply?

This opportunity may be relevant to clinical research professionals who have:

• A relevant Master’s degree in life sciences, preferably Pharmacy.
• 1–2 years of independent onsite clinical monitoring experience.
• Experience conducting clinical trial site visits across India.
• Knowledge of ICH-GCP and applicable clinical research regulations.
• Strong communication and interpersonal skills.
• Experience with clinical trial documentation.
• Knowledge of risk-based monitoring concepts.
• Strong critical-thinking and problem-solving abilities.
• Oncology clinical trial monitoring experience, preferably.

How to Apply

Application Link