Job Title: Clinical Research Associate (CRA) – Level II
Location: Remote – India
Job ID: R-01326248
Employment Type: Full-Time
Category: Clinical Research
Work Mode: Fully Onsite
Work Schedule: Standard (Monday to Friday)
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science with a mission to make the world healthier, cleaner, and safer. Our Clinical Research team, powering the PPD® clinical research portfolio, delivers expert scientific and clinical services to accelerate drug development worldwide.
Role Overview
As a CRA Level II, you will play a critical role in clinical trial monitoring and site management to ensure protocols and regulatory compliance. You will work closely with investigational sites to manage clinical monitoring activities, ensuring high-quality, compliant, and cost-effective clinical trials.
Key Responsibilities
Perform and coordinate clinical monitoring and site management activities through remote and on-site visits.
Ensure clinical trials are conducted in accordance with protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
Monitor investigator sites using risk-based monitoring approaches, applying root cause analysis and problem-solving techniques.
Review clinical data for accuracy via Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review.
Assess investigational product inventory and documentation.
Document observations in reports and letters using approved writing standards.
Escalate deficiencies or issues to clinical management and follow through resolution.
Maintain regular communication with investigational sites between visits to ensure compliance and data integrity.
Participate in investigator meetings and site initiation activities.
Facilitate trial closeout and retrieval of trial materials.
Ensure essential documents are complete and compliant with ICH-GCP and regulatory requirements.
Conduct on-site file reviews as per project guidelines.
Provide trial status updates and progress reports to the Clinical Team Manager (CTM).
Maintain study systems and facilitate effective communication between investigative sites, clients, and project teams.
Respond to audits, inspections, and company or client requests.
Complete administrative tasks including expense reports and timesheets on time.
Contribute to project team efforts, process improvements, and preparation of project-related publications/tools.
Job Complexity
Addresses problems of limited scope using standard practices and procedures.
Receives detailed instructions and guidance on work.
Builds stable working relationships primarily within the department.
Qualifications
Education
Bachelor’s degree in a life-related field, or
Registered Nursing certification, or
Equivalent formal academic/vocational qualifications.
Experience
Minimum 2+ years experience as an onsite clinical research monitor or equivalent.
Valid driver’s license where applicable.
Equivalent combinations of education, training, and experience considered.
Skills & Abilities
Proven clinical monitoring skills.
Knowledge of medical/therapeutic areas and medical terminology.
Working knowledge of ICH-GCP, applicable regulations, and procedural documents.
Strong critical thinking, root cause analysis, and problem-solving skills.
Experience managing Risk-Based Monitoring (RBM) concepts and processes.
Excellent oral and written communication skills.
Customer-focused with strong listening skills and attention to detail.
Strong organizational, time management, and interpersonal skills.
Ability to work independently and in teams.
Proficient in Microsoft Office and ability to learn relevant software.
Good command of English language, grammar, and presentation skills.
Work Environment
Ability to communicate effectively with diverse groups.
Able to work upright and stationary for typical work hours.
Comfortable working in non-traditional work environments.
Proficient with office equipment and technology.
Ability to perform under pressure and manage multiple tasks.
May have exposure to hazardous elements common in healthcare or laboratory environments.
Required independent travel up to a specified percentage (automobiles, airplanes, trains).
Accessibility & Equal Opportunity
Thermo Fisher Scientific ensures reasonable accommodation for individuals with disabilities throughout the application and employment process. Please contact us to request accommodations.
We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, genetic information, veteran status, age, or disability.
Learn More & Apply
Visit: www.thermofisher.com
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