Clinical Research Associate (CRA I, CRA II & Senior CRA)
Location: Onsite, India
Job ID: R-01326248
Employment Type: Full-Time
Category: Clinical Research
Work Mode: Fully Onsite
Work Schedule: Standard (Monday to Friday)
About the Opportunity
A leading global Contract Research Organization (CRO), part of Thermo Fisher Scientific’s PPD® clinical research services, is seeking qualified Clinical Research Associates (CRA I, CRA II, and Senior CRA) to support end-to-end clinical trial operations. This role offers the opportunity to contribute directly to the development of life-changing therapies across diverse therapeutic areas and global clinical programs.
Clinical Operations teams provide comprehensive support from study start-up through monitoring and close-out, delivering high-quality, compliant, and cost-effective clinical trials across commercial and government-sponsored studies.
Key Responsibilities
Perform and coordinate all aspects of clinical monitoring and site management activities
Conduct onsite and remote monitoring visits to assess protocol compliance, regulatory adherence, and data integrity
Ensure trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
Apply risk-based monitoring methodologies, including root cause analysis (RCA) and corrective and preventive action (CAPA) planning
Review source data, perform source data verification (SDV), source data review (SDR), and CRF review as required
Assess investigational product accountability through inventory and documentation review
Document monitoring observations clearly and accurately in monitoring reports and follow-up letters
Escalate quality, compliance, and site performance issues to clinical management and ensure timely resolution
Maintain regular communication with investigative sites between monitoring visits
Support investigator payments and participate in investigator meetings as required
Assist in site identification, selection, initiation, monitoring, and close-out activities
Ensure essential trial documentation is complete, accurate, and audit-ready
Update study systems such as Clinical Trial Management Systems (CTMS) according to project requirements
Facilitate effective communication between investigative sites, sponsors, and cross-functional project teams
Support regulatory inspections, audits, and client requirements
Complete administrative tasks, including expense reports and timesheets, in a timely manner
Contribute to process improvement initiatives and project-level activities
Education Requirements
Bachelor’s degree in Life Sciences or a related field, or Registered Nursing qualification
Equivalent combinations of education, training, and relevant experience may be considered
Experience Requirements (by Level)
CRA Level I:
Minimum 1–2 years of clinical research experience or equivalent exposure to clinical trial operations
Foundational knowledge of clinical monitoring principles
CRA Level II:
Minimum 2–4 years of onsite clinical monitoring experience
Demonstrated ability to independently manage assigned investigative sites
Senior CRA:
Minimum 4–6+ years of clinical monitoring experience in a pharmaceutical or CRO environment
Proven expertise in complex trials, mentoring junior CRAs, and managing high-risk sites
Valid driver’s license and ability to travel as required
Required Skills and Competencies
Strong clinical monitoring and site management expertise
Working knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial documentation
Understanding of medical terminology and therapeutic area concepts
Proficiency in risk-based monitoring strategies and compliance management
Strong critical thinking, problem-solving, and root cause analysis skills
Excellent written and verbal communication skills in English
Strong organizational, time management, and prioritization abilities
Effective interpersonal and stakeholder management skills
High attention to detail and data accuracy
Ability to work independently and collaboratively in cross-functional teams
Proficiency in Microsoft Office and ability to learn clinical trial systems and software
Work Environment and Travel
Onsite role based in India with non-traditional work environments as required
Ability to work under pressure while managing multiple priorities
May involve exposure to healthcare or laboratory environments
Independent travel up to a significant percentage, including domestic travel by car, train, or air
Why Join This Organization
Employees are supported in creating a balanced and healthy work environment while contributing to global clinical research initiatives. The organization offers access to large-scale international trials, structured career progression across CRA levels, and opportunities to work with innovative clinical trial models, including decentralized and digital solutions.
Equal Employment Opportunity
The organization is committed to equal employment opportunities and values diversity and inclusion across its global workforce.
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