Sr CRA (Level I) - FSP

Thermo Fisher Scientific

About The Position

The Senior Clinical Research Associate (Level I) performs and coordinates clinical monitoring and site management activities. The role conducts remote and on-site visits to assess protocol and regulatory compliance, manage required documentation, and apply procedures from different sponsors and monitoring environments. As a site processes specialist, the CRA helps ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and supporting reliable data. The role also supports audit readiness and collaborative relationships with investigative sites. The position monitors investigator sites using a risk-based approach, reviews data and investigational product records, documents and escalates issues, tracks study progress, and helps resolve findings. It supports site selection, initiation, ongoing conduct, and closeout; maintains essential documents and study systems; and communicates with investigative sites, clients, and project teams. Additional duties include supporting project materials and process-improvement work and completing administrative tasks. Work is performed in an office, laboratory, clinical, and/or home-office environment, with frequent driving to sites and frequent travel, generally 60–80% and sometimes more. Extended overnight stays may be required. The role may involve exposure to biological fluids and infectious organisms, electrical office equipment, and, rarely, fluctuating or extreme temperatures. Required personal protective equipment includes protective eyewear, garments, and gloves. The employee must comply with applicable sponsor, client, and site requirements, which may include disclosure of vaccination status or other personal information.

Requirements

Bachelor’s degree in a life-sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
At least 3 years of completed on-site clinical monitoring experience.
At least 1.5 years of completed experience as lead CRA on oncology clinical trials.
Effective clinical monitoring skills.
Demonstrated understanding of medical or therapeutic-area knowledge and medical terminology.
Excellent understanding and demonstrated application of ICH-GCP, applicable regulations, and procedural documents.
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.
Effective oral and written communication skills, including the ability to communicate effectively with medical personnel.
Ability to maintain customer focus through listening, attention to detail, and recognition of customers’ underlying issues.
Effective interpersonal skills and strong attention to detail.
Effective organizational and time-management skills.
Ability to remain flexible and adaptable across a wide range of scenarios.
Ability to work independently or as part of a team, as required.
Proficiency with Microsoft Office and ability to learn appropriate software.
Good English language and grammar skills.
Good presentation skills.
Ability to travel frequently, generally 60–80% and potentially more, including frequent driving to sites and possible extended overnight stays.
Ability to comply with sponsor, client, and site requirements, including possible disclosure of vaccination status or other personal information.
Ability to use required personal protective equipment and work in environments with potential exposure to biological fluids and infectious organisms.

Responsibilities

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 or preventive actions.
Ensure data accuracy through source document review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable, during remote and on-site monitoring.
Assess investigational product through physical inventory and records review.
Document observations in reports and letters promptly and in accordance with approved business-writing standards.
Escalate observed deficiencies and issues to clinical management promptly and follow issues through to 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.
Provide trial-status tracking and progress reports to the Clinical Team Manager (CTM) as required.
Update study systems, including the Clinical Trial Management System (CTMS), according to agreed study conventions, and perform quality checks of CTMS-generated reports when required.
Participate in investigator meetings as necessary.
Identify potential investigators with the client company and assess the acceptability of qualified investigative sites.
Initiate clinical trial sites according to applicable procedures and make recommendations to support protocol, regulatory, and ICH-GCP compliance.
Ensure trial closeout and retrieval of trial materials.
Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations; conduct on-site file reviews as specified by the project.
Assist with preparation of project publications and tools and share ideas with team members.
Perform additional study tasks assigned by the CTM, such as trip-report review, newsletter creation, and leading CRA team calls.
Facilitate communication among investigative sites, the client company, and the PPD project team 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.
Contribute to other project work and process-improvement initiatives as required.