CRA (Level I)

Job Description

The CRA Level I performs and coordinates different aspects of the clinical monitoring and site management process. The role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. The CRA manages procedures and guidelines across different sponsors and/or monitoring environments, including FSO, FSP, and Government environments. The CRA acts as a site processes specialist, ensuring clinical trials are conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, with the objective of protecting subjects' rights and well-being and ensuring data reliability and audit readiness. The role also develops collaborative relationships with investigational sites.

Key Responsibilities

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving to identify process failures and implement corrective/preventive actions.
• Ensure data accuracy through SDR, SDV, and CRF review, as applicable, through on-site and remote monitoring.
• Assess investigational product through physical inventory and records review.
• Document monitoring observations in reports and letters and promptly escalate deficiencies or issues to clinical management, following them through resolution.
• Maintain contact with investigational sites between monitoring visits to confirm protocol adherence, resolution of previously identified issues, and timely data recording.
• Conduct monitoring activities according to the approved monitoring plan.
• Participate in investigator payment processes and collaborate with project team members on issue/finding resolution.
• Participate in investigator meetings and potentially assist with identifying qualified investigators/sites.
• Initiate clinical trial sites according to applicable procedures and ensure compliance with protocol, regulatory, and ICH-GCP obligations.
• Perform trial close-out activities and retrieval of trial materials.
• Ensure required essential documents are complete and available according to ICH-GCP and applicable regulations, including conducting on-site file reviews.
• Provide trial status tracking and progress reports.
• Ensure study systems, including Clinical Trial Management Systems (CTMS), are complete, accurate, and up to date.
• Facilitate effective communication among investigative sites, clients, and internal project teams.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks such as expense reports and timesheets.
• Assist the project team in preparing project publications/tools and contribute ideas and suggestions.
• Participate in project work and process-improvement initiatives.
• Travel extensively; the document specifies a travel requirement higher than 75%, while the working-conditions section describes travel as generally 60–80%, potentially more for some individuals.

Qualifications — Education & Experience

Education

• Bachelor's degree in a life sciences-related field.

Experience

• Minimal clinical monitoring experience sufficient to perform the role, described as comparable to approximately 2 years.
• Relevant experience may come from clinical trials, medical terminology, medical research, clinical research, healthcare, or a health sciences field with formal training in medical terminology and anatomy.
• Valid driver's license where applicable.
• An appropriate combination of education, training, and directly related experience may be accepted as an equivalent qualification.

Knowledge, Skills & Abilities

The position requires:

• Basic medical/therapeutic-area knowledge and understanding of medical terminology.
• Ability to attain and maintain working knowledge of ICH-GCP, applicable regulations, and procedural documents.
• Good oral and written communication skills, including communication with medical personnel.
• Good interpersonal skills.
• Customer focus, listening skills, attention to detail, and ability to identify underlying customer issues.
• Good organizational and time-management skills.
• Flexibility and adaptability across different situations.
• Well-developed critical thinking, investigation, root cause analysis, and problem-solving skills.
• Ability to manage Risk-Based Monitoring (RBM) concepts and processes.
• Ability to work independently or as part of a team.
• Good computer skills, including solid Microsoft Office knowledge and ability to learn relevant software.
• Good English language and grammar skills.