CRA (Level I)

Thermo Fisher Scientific

About The Position

The Clinical Research Associate I performs and coordinates clinical monitoring and site management activities, including remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. The role manages sponsor and monitoring-environment procedures and guidelines and supports trial conduct in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, helping protect participants’ rights and well-being and ensure reliable data. The associate supports audit readiness and develops collaborative relationships with investigational sites. The role involves risk-based monitoring, data review, investigational product assessment, site initiation and closeout, essential-document management, trial-status tracking, and communication among investigative sites, clients, and internal teams. Work is performed in office, laboratory, clinical, and/or home-office environments, with frequent travel to sites, generally 60–80%, and possible extended overnight stays.

Requirements

Bachelor’s degree in a life-sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
Minimal clinical monitoring experience sufficient to perform the job, comparable to 2 years, in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, or health care; alternatively, experience in a health-sciences field with formal training in medical terminology and anatomy may be considered.
Valid driver’s license where applicable.
Basic medical or 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 the ability to communicate effectively with medical personnel.
Good interpersonal skills.
Ability to maintain customer focus through listening, attention to detail, and recognition of customers’ underlying issues.
Good organizational and time-management skills.
Ability to remain flexible and adaptable in a wide range of scenarios.
Well-developed critical-thinking skills, including a critical mindset, in-depth investigation for root cause analysis, and problem solving.
Ability to manage risk-based monitoring concepts and processes.
Ability to work independently or as part of a team as required.
Good computer skills, including solid knowledge of Microsoft Office and ability to learn relevant software.
Good English language and grammar skills.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach; identify site-process failures and corrective or preventive actions through root cause analysis, critical thinking, and problem solving.
Ensure data accuracy through source document review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable, during on-site and remote monitoring.
Assess investigational product through physical inventory and records review.
Document observations in reports and letters in a timely manner using approved business-writing standards.
Escalate deficiencies and issues to clinical management and follow them through resolution.
Maintain contact with investigative sites between monitoring visits as needed to confirm protocol compliance, issue resolution, and timely data recording.
Conduct monitoring tasks in accordance with the approved monitoring plan.
Participate in the investigator payment process and share responsibility with project team members for resolving issues and findings.
Participate in investigator meetings as necessary.
Help identify potential investigators with the client company as needed.
Initiate clinical trial sites according to applicable procedures and make recommendations to support compliance with protocols, regulations, and ICH-GCP obligations.
Perform trial closeout and retrieval of trial materials.
Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations; conduct on-site file reviews as specified by the project.
Provide trial-status tracking and progress updates to the team as required.
Keep study systems, such as the Clinical Trial Management System, complete, accurate, and current according to agreed study conventions.
Facilitate effective communication among investigative sites, the client company, and internal project teams through written, oral, and electronic contacts.
Respond to company, client, and applicable regulatory requirements, audits, and inspections.
Complete administrative tasks, including expense reports and timesheets, in a timely manner.
Assist with preparation of project publications and tools, share suggestions with team members, and contribute to other project work and process-improvement initiatives as required.