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 documentation, and ensure trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. The CRA supports subjects’ rights and well-being, data reliability, audit readiness, and productive relationships with investigational sites. The position may involve managing procedures and guidelines across different sponsors and monitoring environments.

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.
Effective clinical monitoring skills.
Understanding of medical or therapeutic area knowledge and medical terminology.
Strong understanding and demonstrated application of ICH-GCP, applicable regulations, and procedural documents.
Critical-thinking skills, including a critical mindset, in-depth root-cause investigation, and problem-solving ability.
Ability to manage risk-based monitoring concepts and processes.
Effective oral and written communication skills, including the ability to communicate with medical personnel.
Customer focus, good listening skills, attention to detail, and ability to recognize customers’ underlying issues.
Effective interpersonal skills and strong attention to detail.
Effective organizational and time-management skills.
Ability to remain flexible and adaptable in a wide range of scenarios.
Ability to work independently or as part of a team.
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 to make frequent drives to site locations; extended overnight stays may be required.
Ability to comply with specific sponsor, client, or site requirements, which may include disclosure of vaccination status or other personal information.

Nice To Haves

Experience in infectious disease (pneumonia) and ophthalmology clinical studies.

Responsibilities

Monitor investigator sites using a risk-based approach; investigate site process failures, perform root-cause analysis, and support corrective and preventive actions.
Ensure data accuracy through source data review, source data verification, and case report form review, as applicable, during on-site and remote monitoring.
Assess investigational product through physical inventory and records review.
Document monitoring observations in reports and letters promptly and according to approved business writing standards.
Escalate observed deficiencies and issues to clinical management and follow them 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 according to the approved monitoring plan and participate in investigator payments.
Share responsibility with project team members for resolving issues and findings, and investigate and follow up on findings as applicable.
Provide trial status tracking and progress updates to the Clinical Team Manager as required.
Update study systems, such as the Clinical Trial Management System, according to agreed study conventions, and perform quality checks of CTMS reports where required.
Participate in investigator meetings as necessary.
Identify potential investigators with the client company, initiate clinical trial sites, and recommend actions as warranted to support compliance with protocol, regulatory, and ICH-GCP requirements.
Ensure trial closeout and retrieval of trial materials.
Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations, and conduct on-site file reviews as specified by the project.
Assist with project publications and tools, share ideas with team members, and perform additional study tasks assigned by the Clinical Team Manager.
Facilitate effective communication among investigative sites, the client company, and the project team.
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.