CRA II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage clinical trial documentation, procedures, and sponsor-specific guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs
• Maintain audit readiness and collaborative relationships with investigational sites
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions
• Ensure data accuracy through source data review, source data verification, and CRF review
• Assess investigational product through inventory and records review
• Document observations in reports and letters; escalate and follow issues through resolution
• Maintain contact with sites between visits to confirm protocol compliance, issue resolution, and timely data recording
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payment processes and investigator meetings
• Investigate and follow up on findings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and maintained according to ICH-GCP and regulations
• Conduct on-site file reviews
• Provide trial status tracking and progress reports to the Clinical Team Manager
• Update study systems such as CTMS
• Facilitate communication among investigative sites, the client, and the PPD project team
• Respond to company, client, regulatory, audit, and inspection requirements
• Complete expense reports and timesheets
• Support project publications, tools, process improvements, and other project initiatives
• Travel frequently, including possible extended overnight stays

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• At least 1 year of experience as a clinical research monitor
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Valid driver's license where applicable
• Proven clinical monitoring skills
• Understanding of medical/therapeutic areas and medical terminology
• Working knowledge of ICH GCPs, applicable regulations, and procedural documents
• Critical thinking, root cause analysis, and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills
• Customer focus, listening skills, attention to detail, and ability to identify underlying issues
• Organizational and time management skills
• Interpersonal skills
• Flexibility and adaptability
• Ability to work independently and in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Ability to work in an office, laboratory, clinical, and/or home office environment
• Ability to travel frequently, generally 60–80% or more than 75% depending on the stated requirement
• Ability to comply with sponsor, client, and site requirements, including possible disclosure of vaccination status or other personal information
• Ability to work upright and/or stationary for 6–8 hours per day
• Frequent mobility; occasional crouching and stooping; frequent bending and twisting
• Ability to lift and carry light to moderate loads, including luggage and a laptop
• Ability to use varied computer software
• Ability to communicate complex information and understand spoken information
• Ability to perform under stress, multitask, and maintain regular attendance

• Fully remote work mode
• Standard Monday–Friday work schedule
• Opportunity to work on clinical trials for major pharmaceutical and biotechnology companies
• Professional development through exposure to diverse sponsors, monitoring environments, therapeutic areas, and clinical research projects