Work Schedule

Environmental Conditions

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.